Clinical Lead I Remote Jobs

9 Results

14d

Clinical Lead II - Bulgaria

Premier ResearchRemote, Sofia, Bulgaria
Design

Premier Research is hiring a Remote Clinical Lead II - Bulgaria

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.  

We’re looking for a Clinical Lead II to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. The role can be filled in Europe in the country, where we have our entity.

As a Clinical Lead here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation. 

What you’ll be doing:
  • Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
  • Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
  • Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
  • Drive the successful activation of trial sites according to time, quality/scope and budget parameters
  • Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
  • Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
  • Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
  • Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
  • Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
  • Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
  • Actively participate in Bid Defense activities

You’ll need this to be considered:

  • Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
  • 7 years of clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring)
  • 3 years of previous Clinical Oversight experience as a Clinical Lead
  • Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
  • Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Fluent verbal and written English as well as the local language(s) required
  • Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
  • Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-BC1
#Remote

See more jobs at Premier Research

Apply for this job

Premier Research is hiring a Remote Clinical Lead II/III - Belgium

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.  

We’re looking for a Clinical Lead II/III to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. The role can be filled in Europe in the country, where we have our entity.

As a Clinical Lead here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation. 

What you’ll be doing:
  • Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
  • Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
  • Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
  • Drive the successful activation of trial sites according to time, quality/scope and budget parameters
  • Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
  • Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
  • Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
  • Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
  • Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
  • Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
  • Actively participate in Bid Defense activities

You’ll need this to be considered:

  • Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
  • 7 years of clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring)
  • 3 years of previous Clinical Oversight experience as a Clinical Lead
  • Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
  • Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Fluent verbal and written English as well as the local language(s) required
  • Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
  • Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-BC1
#Remote

See more jobs at Premier Research

Apply for this job

Premier Research is hiring a Remote Clinical Lead II/III - Bulgaria

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.  

We’re looking for a Clinical Lead II/III to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. The role can be filled in Europe in the country, where we have our entity.

As a Clinical Lead here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation. 

What you’ll be doing:
  • Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
  • Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
  • Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
  • Drive the successful activation of trial sites according to time, quality/scope and budget parameters
  • Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
  • Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
  • Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
  • Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
  • Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
  • Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
  • Actively participate in Bid Defense activities

You’ll need this to be considered:

  • Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
  • 7 years of clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring)
  • 3 years of previous Clinical Oversight experience as a Clinical Lead
  • Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
  • Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Fluent verbal and written English as well as the local language(s) required
  • Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
  • Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-BC1
#Remote

See more jobs at Premier Research

Apply for this job

Premier Research is hiring a Remote Clinical Lead II/III - Germany

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.  

We’re looking for a Clinical Lead II/III to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. The role can be filled in Europe in the country, where we have our entity.

As a Clinical Lead here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation. 

What you’ll be doing:
  • Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
  • Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
  • Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
  • Drive the successful activation of trial sites according to time, quality/scope and budget parameters
  • Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
  • Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
  • Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
  • Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
  • Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
  • Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
  • Actively participate in Bid Defense activities

You’ll need this to be considered:

  • Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
  • 7 years of clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring)
  • 3 years of previous Clinical Oversight experience as a Clinical Lead
  • Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
  • Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Fluent verbal and written English as well as the local language(s) required
  • Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
  • Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-BC1
#Remote

See more jobs at Premier Research

Apply for this job

Premier Research is hiring a Remote Clinical Lead II/III - Netherlands

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.  

We’re looking for a Clinical Lead II/III to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. The role can be filled in Europe in the country, where we have our entity.

As a Clinical Lead here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation. 

What you’ll be doing:
  • Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
  • Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
  • Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
  • Drive the successful activation of trial sites according to time, quality/scope and budget parameters
  • Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
  • Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
  • Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
  • Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
  • Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
  • Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
  • Actively participate in Bid Defense activities

You’ll need this to be considered:

  • Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
  • 7 years of clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring)
  • 3 years of previous Clinical Oversight experience as a Clinical Lead
  • Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
  • Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Fluent verbal and written English as well as the local language(s) required
  • Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
  • Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-BC1
#Remote

See more jobs at Premier Research

Apply for this job

Premier Research is hiring a Remote Clinical Lead II/III - Spain

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.  

We’re looking for a Clinical Lead II/III to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. The role can be filled in Europe in the country, where we have our entity.

As a Clinical Lead here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation. 

What you’ll be doing:
  • Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
  • Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
  • Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
  • Drive the successful activation of trial sites according to time, quality/scope and budget parameters
  • Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
  • Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
  • Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
  • Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
  • Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
  • Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
  • Actively participate in Bid Defense activities

You’ll need this to be considered:

  • Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
  • 7 years of clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring)
  • 3 years of previous Clinical Oversight experience as a Clinical Lead
  • Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
  • Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Fluent verbal and written English as well as the local language(s) required
  • Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
  • Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-BC1
#Remote

See more jobs at Premier Research

Apply for this job

Premier Research is hiring a Remote Clinical Lead II/III - United Kingdom

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.  

We’re looking for a Clinical Lead II/III to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. The role can be filled in Europe in the country, where we have our entity.

As a Clinical Lead here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation. 

What you’ll be doing:
  • Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
  • Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
  • Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
  • Drive the successful activation of trial sites according to time, quality/scope and budget parameters
  • Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
  • Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
  • Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
  • Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
  • Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
  • Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
  • Actively participate in Bid Defense activities

You’ll need this to be considered:

  • Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
  • Solid clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring)
  • Strong previous Clinical Oversight experience as a Clinical Lead
  • Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
  • Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Fluent verbal and written English as well as the local language(s) required
  • Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
  • Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-BC1
#Remote

See more jobs at Premier Research

Apply for this job

+30d

Clinical Lead II - Remote (United States)

Premier ResearchRemote, United States
Bachelor's degree

Premier Research is hiring a Remote Clinical Lead II - Remote (United States)

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Clinical Lead II to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you'll be doing:

  • Driving and managing the clinical components of the Start up process from site ID to qualification and site activation.
  • Training and management of the CRA team for the lifecycle of project, including: Monitoring visit forecasting/resource management; Adherence to the protocol, SOPs/regulations and project plans; Ensuring data quality and patient safety
  • Creates and maintains, in a timely fashion, study specific clinical monitoring plans (CMP) utilizing approved templates ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
  • Ensures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues
  • Plans and drives both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestones
  • Apply a risk-based quality management mindset in order to proactively mitigate issues and also provide support for study audits and responses

What we are searching for:

  • Bachelor's degree, or local equivalent, in a clinical, biological, scientific, or health-related field
  • 5+ years of clinical research/monitoring experience is preferred
  • 1+ years of previous Clinical Oversight experience (clinical trial manager) within a Clinical Research Organization

Why choose Premier Research?

  • Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

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+30d

Clinical Lead III - Remote (United States)

Premier ResearchRemote, United States
Bachelor's degree

Premier Research is hiring a Remote Clinical Lead III - Remote (United States)

Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Clinical Lead III to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you'll be doing:

  • Driving and managing the clinical components of the Start up process from site ID to qualification and site activation.
  • Training and management of the CRA team for the lifecycle of project, including: Monitoring visit forecasting/resource management; Adherence to the protocol, SOPs/regulations and project plans; Ensuring data quality and patient safety
  • Creates and maintains, in a timely fashion, study specific clinical monitoring plans (CMP) utilizing approved templates ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
  • Ensures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues
  • Plans and drives both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestones
  • Apply a risk-based quality management mindset in order to proactively mitigate issues and also provide support for study audits and responses

What we are searching for:

  • Bachelor's degree, or local equivalent, in a clinical, biological, scientific, or health-related field
  • 7+ years of clinical research/monitoring experience is preferred
  • 3+ years of previous Clinical Oversight experience (clinical trial manager) within a Clinical Research Organization

Why choose Premier Research?

  • Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

#LI-KH1
#LI-Remote 

See more jobs at Premier Research

Apply for this job