Job Description

We are seeking a dynamic and motivated Business Development Representative to join our team. This individual will be responsible for identifying, engaging, and recruiting physicians to join our Clinical Trial Site Enablement Organization (SEO). The ideal candidate will have a strong background in healthcare and clinical research within an SMO or in a Site Networking role, excellent communication skills, and a passion for advancing medical innovation through clinical trials.

Key Responsibilities:

• Physician Outreach: Proactively reach out to physicians, medical practices, and healthcare providers to discuss opportunities for participating in clinical trials.
• Relationship Building: Develop and maintain long-term relationships with physicians, building trust and credibility through understanding their needs and addressing concerns related to clinical research participation.
• Screening and Qualification: Evaluate physicians' qualifications, practice types, patient demographics, and interest in clinical research to determine suitability for partnership with the SEO.
• Collaboration: Work closely with internal teams, including clinical trial managers, business development, and marketing, to align recruitment strategies with organizational goals. Comfortable interacting with an executive level audience both internally and with potential clients.
• Market Research: Conduct research to identify target physician groups based on specialties, geographic location, and patient populations that align with upcoming clinical trials.
• Contract Negotiation: Support the process of contracting physicians and clinical sites, ensuring mutually beneficial terms and compliance with organizational policies.
• Database Management: Maintain accurate and up-to-date records of physician recruitment activities in CRM systems, ensuring all data is organized and accessible for reporting.
• Event Coordination: Participate in and help organize physician networking events, conferences, webinars, and other recruitment initiatives.

Qualifications

• Education: Bachelor’s degree in life sciences, healthcare administration, business, or related field. Master’s degree preferred but not required.
• Experience:
  • 5+ years of experience in physician recruitment, clinical research sales, site networking or clinical research coordination.
  • Experience in clinical trials or site management is highly desirable.
• Skills:
  • Strong interpersonal and communication skills, both verbal and written.
  • Ability to build rapport with physicians and healthcare professionals.
  • Understanding of clinical trial processes, regulatory requirements, and the healthcare industry.
  • Proficient in CRM systems and data management tools.
• Personal Attributes:
  • Self-motivated and results-oriented with a passion for healthcare and clinical research.
  • Strong organizational skills and attention to detail.
  • Ability to work independently and as part of a team in a fast-paced environment.

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Job Description

Full-time employment in Estonia

As a Full stack Developer you will be involved in development of projects for internal clients and will provide quality coding to support PSI business processes and operations. 

You will:

• Architect, develop and maintain business applications
• Process user requests for developing of new and support for existing IT systems
• Prepare documentation related to development and maintenance of business applications
• Execute and implement software tests, participate in code reviews
• Follow the development standards applied within the department
• Track the development, maintenance and related tasks in the tracking system used within the team
• Follow the progress of systems development technologies and advance professional skills as necessary

Qualifications

The ideal candidate will have:

• Knowledge of building web-based applications
• Knowledge of web technologies including JS(ES+), Typescript, HTML5, CSS, Webpack
• Knowledge of C# language, Microsoft .NET frameworks, Blazor, technologies and best practices
• Knowledge of unit-testing, knowledge of other testing methods is a plus
• Knowledge of Transact SQL, MS SQL functions, stored procedures and other SQL objects
• Familiarity with software analysis, testing and debugging code
• Ability to write high-quality, efficient and easily testable code
• Team-oriented, deadline-driven, with good communication skills
• BSc/BA in computer science, software engineering or relevant discipline
• Full working proficiency in English

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Job Description

Only CV's in English will be considered

We are looking for a CRA to join our team in Mexico. Here you will have the opportunity to develop yourself as a senior, trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring.

Responsibilities will include:

• Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
• Delivering training of investigators, site staff and project teams
• Work with complex studies
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be involved in site identification process
• Contact for clinical investigators, vendors and support services in regard to study progress
• Participate in feasibility research
• Preparation and delivering of presentations at Investigator’s Meetings
• Preparation for and attendance at company’s audits; resolution of audit findings
• Support to Regulatory Affairs in procurement of site regulatory documents
• Maintenance of study-specific automated tracking systems

Qualifications

• Bachelor's degree in Medicine
• At least 2 years experience in patient care and/or health care or clinical environment
• Full working proficiency in Spanish and English
• Experience in Clinical Research is a plus
• Availability to travel
• Proficiency in MS Office applications
• Ability to plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

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Job Description

• Assesses feasibility of research protocols based on knowledge and experience and in accordance with designated criteria to select the most suitable studies for the clinical site.  

• Supervises the conduct of clinical trials in accordance with ICH GCP, applicable regulations, procedures, and protocols, by monitoring the safety of patients, completeness of research documentation and proper study conduct. 

• Monitors individual stages of budget negotiations and research timelines. 

• Manages the team of Lead Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and any other available tools to ensure satisfactory performance of the MO1 team. 

• Ensures continuous improvement and standardization of the research process, its continuity and consistency with ICH GCP, regulations, procedures and research protocols by co-creating operational procedures, templates, guidelines related to the work of medical staff and the site in clinical studies. 

• Creates a work culture environment that promotes process transparency, high performance and openness. 

• Manages and supervises the teams’ work, ensuring the development of individual team members through regular, open feedback, periodic support meetings, providing training and guidance.  Provides performance evaluation in accordance with the employee evaluation system to maintain motivation and commitment at work.  

• Supervises and participates, when necessary, in audits and inspections, supports the Milestone One team and the medical team at the site by ensuring a reliable and smooth audit process.

Qualifications

College or university degree in life sciences and minimum 5 years of experience in a leadership position at a CRO or SMO is vital.

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Job Description

We are currently looking for a knowledgeable and proactive MS SQL Database Developer to join our Systems Development Team.

Full-time employment in Latvia

You will:

• Develop and maintain information systems based on MS SQL
• Process user requests for developing new IT systems and supporting existing ones
• Develop and maintain documentation related to database structure, database objects and instructions thereof
• Develop, implement and maintain automated and manual processes for database backup and related operations
• Track the development, maintenance and related tasks in the internal tracking system
• Participate in design, development and implementation of database systems based on user requirements
• Extract, transform, load data from various sources
• Develop security procedures to protect databases from unauthorized access
• Optimize database systems for performance and efficiency

Qualifications

• Bachelor's degree in IT or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities
• 2 years’ experience as a Database Developer or similar position
• Database administration experience
• Experience in software development is a plus
• Full working proficiency in English
• Experience in generating complex data queries using Transact SQL
• Experience in developing MS SQL functions, stored procedures, and other SQL objects
• Experience in database design and architecting process is a plus

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Job Description

We are seeking an experienced Clinical Research Billing Specialist to join our Site Enabling Organization (SEO). This role is critical for ensuring accurate and compliant billing of clinical research activities from the site side, with particular attention to differentiating between research-related services and standard of care (SOC) services. The ideal candidate will have deep expertise in clinical trial financial operations, research billing compliance, and a thorough understanding of standard of care (SOC) billing practices. You will ensure proper invoicing of clinical trial services in accordance with contracts, while maintaining regulatory compliance.

Key Responsibilities:

• Billing Management: Oversee and manage billing processes for clinical research activities at the site, ensuring accurate billing of research-related services to sponsors and proper consideration related to site billing of standard of care (SOC) services to third-party payers (e.g., Medicare, private insurers).
• Budget Review & Development:
  • Work with site staff, sponsors, and clinical research coordinators to review and negotiate clinical trial budgets, utilizes the research fee schedule to develop the per patient and pass through budgets for those billable items and services which cannot be billed to third party payers. Ensures that all costs and effort to conduct the study are appropriately covered within the study budget.
  • Thoroughly reviews complex study protocols, Informed Consent Documents, draft sponsor Clinical Trial Agreements , and budgets to identify all billable items and services required of the study which might generate a CPT code. Documents the CPT codes at the respective visits for all billable items and services to be paid by the grant.
• Compliance Monitoring: Ensure all billing activities align with regulatory guidelines, including federal and state laws regarding clinical trial billing, Medicare regulations, and ethical billing practices.
• Invoice Generation & Reconciliation: Create and issue invoices to sponsors for research-related services per clinical trial agreements.
• Financial Reporting: Prepare detailed financial reports on billing activities, accounts receivable, and payment reconciliation for internal stakeholders and sponsors. Provide guidance to stakeholders to help them drive compliance with SOC requirements.
• Site Support: Provide training and guidance to research sites on distinguishing and appropriately billing standard of care services versus research-related services. Assist sites in understanding clinical trial agreements, budgets, and billing procedures.
• Data Management: Maintain accurate and organized financial records related to clinical trials in the billing system, ensuring that all research-related services are clearly tracked and documented.

Qualifications

• Education: Bachelor’s degree in finance, healthcare administration, or related field. Equivalent work experience may be considered.
• Experience:
  • 3+ years of experience in clinical research billing, revenue cycle management, or financial operations within a healthcare or clinical research setting.
  • Expertise in differentiating between standard of care (SOC) services and research-related services.
  • Strong knowledge of clinical trial budgeting, billing processes, clinical processes, medical terminology, clinical research life cycle, and research compliance, including Medicare Coverage Analysis (MCA).
• Skills:
  • Excellent understanding of clinical trial financials, particularly in managing SOC billing vs. research billing.
  • Proficiency in financial management systems and billing software (e.g., CTMS, QuickBooks, SAP, etc.).
  • Strong organizational, analytical, and problem-solving skills.
  • Ability to communicate effectively with internal teams, site personnel, sponsors, and CROs.
• Personal Attributes:
  • Highly detail-oriented with a focus on compliance and accuracy.
  • Strong organizational skills with the ability to manage multiple projects and deadlines.
  • Self-motivated, able to work independently and in collaboration with cross-functional teams.

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Job Description

We are seeking a dynamic and motivated Physician Recruitment Specialist to join our team. This individual will be responsible for identifying, engaging, and recruiting physicians to join our Clinical Trial Site Enablement Organization (SEO). The ideal candidate will have a strong background in healthcare and clinical research, excellent communication skills, and a passion for advancing medical innovation through clinical trials.

Key Responsibilities:

• Physician Outreach: Proactively reach out to physicians, medical practices, and healthcare providers to discuss opportunities for participating in clinical trials.
• Relationship Building: Develop and maintain long-term relationships with physicians, building trust and credibility through understanding their needs and addressing concerns related to clinical research participation.
• Screening and Qualification: Evaluate physicians' qualifications, practice types, patient demographics, and interest in clinical research to determine suitability for partnership with the SEO.
• Collaboration: Work closely with internal teams, including clinical trial managers, business development, and marketing, to align recruitment strategies with organizational goals. Comfortable interacting with an executive level audience both internally and with potential clients.
• Market Research: Conduct research to identify target physician groups based on specialties, geographic location, and patient populations that align with upcoming clinical trials.
• Contract Negotiation: Support the process of contracting physicians and clinical sites, ensuring mutually beneficial terms and compliance with organizational policies.
• Database Management: Maintain accurate and up-to-date records of physician recruitment activities in CRM systems, ensuring all data is organized and accessible for reporting.
• Event Coordination: Participate in and help organize physician networking events, conferences, webinars, and other recruitment initiatives.

Qualifications

• Education: Bachelor’s degree in life sciences, healthcare administration, business, or related field. Master’s degree preferred but not required.
• Experience:
  • 5+ years of experience in physician recruitment, clinical research sales, or clinical research coordination.
  • Experience in clinical trials or site management is highly desirable.
• Skills:
  • Strong interpersonal and communication skills, both verbal and written.
  • Ability to build rapport with physicians and healthcare professionals.
  • Understanding of clinical trial processes, regulatory requirements, and the healthcare industry.
  • Proficient in CRM systems and data management tools.
• Personal Attributes:
  • Self-motivated and results-oriented with a passion for healthcare and clinical research.
  • Strong organizational skills and attention to detail.
  • Ability to work independently and as part of a team in a fast-paced environment.

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Job Description

We are looking for a temporary freelancer Clinical Research Associate to work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. 

Only CVs in English will be considered
Home-based position in Argentina

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup (if applicable)
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in Argentina
• Experience in all types of monitoring visits in Phase II and/or III
• Availability to travel
• Full working proficiency in English and Spanish
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, deal with different tasks and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

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Job Description

Full-time employment in Lithuania

As a Full stack Developer you will be involved in development of projects for internal clients and will provide quality coding to support PSI business processes and operations. 

You will:

• Architect, develop and maintain business applications
• Process user requests for developing of new and support for existing IT systems
• Prepare documentation related to development and maintenance of business applications
• Execute and implement software tests, participate in code reviews
• Follow the development standards applied within the department
• Track the development, maintenance and related tasks in the tracking system used within the team
• Follow the progress of systems development technologies and advance professional skills as necessary

Qualifications

The ideal candidate will have:

• Knowledge of building web-based applications
• Knowledge of web technologies including JS(ES+), Typescript, HTML5, CSS, Webpack
• Knowledge of C# language, Microsoft .NET frameworks, Blazor, technologies and best practices
• Knowledge of unit-testing, knowledge of other testing methods is a plus
• Knowledge of Transact SQL, MS SQL functions, stored procedures and other SQL objects
• Familiarity with software analysis, testing and debugging code
• Ability to write high-quality, efficient and easily testable code
• Team-oriented, deadline-driven, with good communication skills
• BSc/BA in computer science, software engineering or relevant discipline
• Full working proficiency in English

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Job Description

Business Development Representative supports our Business Development team in building and expanding the network of clients.

In this role, you will 

• Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).
• Support Site Development Manager with active promotion of Milestone One brand by acquiring new clinics and building a site network.
• Conduct research on potential clients to build extended network.
• Set up meetings with potential clients to present MO1 business opportunities and benefits of cooperation with Milestone One
• Assist the Marketing team in preparation of promotional materials.
• Attend medical/pharmaceutical conferences, and training workshops as required.

Qualifications

Education: College or university degree, life science is a plus.

Experience: Minimum 5 years of experience in clinical environment as a medical representative dealing with medical institutions and physicians or as a study coordinator working on site.

Knowledge and skills:

• Fluent use of English and local language
• Proficiency in MS Office
• Excellent communication and presentation skills
• Excellent sales skills
• Effective problem solving and result oriented
• Ability to work in a team
• Valid category B driver’s license

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Job Description

We are currently looking for a knowledgeable and proactive MS SQL Database Developer to join our Systems Development Team.

Full-time employment in Latvia

You will:

• Develop and maintain information systems based on MS SQL
• Process user requests for developing new IT systems and supporting existing ones
• Develop and maintain documentation related to database structure, database objects and instructions thereof
• Develop, implement and maintain automated and manual processes for database backup and related operations
• Track the development, maintenance and related tasks in the internal tracking system
• Participate in design, development and implementation of database systems based on user requirements
• Extract, transform, load data from various sources
• Develop security procedures to protect databases from unauthorized access
• Optimize database systems for performance and efficiency

Qualifications

• Bachelor's degree in IT or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities
• 2 years’ experience as a Database Developer or similar position
• Database administration experience
• Experience in software development is a plus
• Full working proficiency in English
• Experience in generating complex data queries using Transact SQL
• Experience in developing MS SQL functions, stored procedures, and other SQL objects
• Experience in database design and architecting process is a plus

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Job Description

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. We are committed to develop our employees in their careers by providing tailored courses and mentoring. 

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup and feasibility research
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Support regulatory team in preparing documents for study submissions

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Independent on-site monitoring experience Mexico
• Experience in all types of monitoring visits in Phase II / III
• Full working proficiency in English and Spanish
• Proficiency in MS Office applications
• Ability to plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel

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Job Description

The scope of responsibilities will include

Start-up Responsibilities:

• Is involved with in-house and on-site activities related to site identification and new clinical trial placement.

• Is involved in setting clinical trials related collaboration with medical professionals.

• Ensures comprehensive internal handovers from Feasibility to Operations.

• Defines the optimal site profile for a study and recommends the best, high-quality sites after contacting and evaluating their capabilities and potential for study conduct.

• Reviews therapeutic indication, and study specific materials prior to contacting sites.

• Creates and/or maintains a site identification tracker.

• Regularly communicates with Project Teams to update them on the status/progress of the site ID, as well as highlights any potential risks or issues to timelines or objectives.

Ongoing Project Responsibilities (all phases):

• Creates and maintains a therapeutic area-specific site database.

• Assists Project Teams during the enrollment phase by identifying additional sites when necessary.

• Develops strategies to accelerate site identification through the use of external databases like Citeline and CenterWatch, contacting SMOs, site networks, advocacy and support groups and central IRBs etc.

• Training: Trains CTAs and CRAs on how to get the best information from sites, acts as a trainer and mentor.

• Business Development and Corporate assignments: Participates in the preparation of presentations for client and bid defense meetings, provides input in various regulatory aspects (as requested).

Qualifications

Qualifications

• Life sciences degree (proven CRA experience is a plus)

• Experience of working in practical healthcare settings (hospital, outpatient clinic) is a strong plus.

• Prior experience in Site Identification/Study Start-Up activities is a strong plus.

• Practical experience in clinical trials related activities (study coordinator, sub-investigator) is a strong plus.

• Excellent written and oral communication skills, as well as time management skills

• Demonstrates the ability to multitask under compressed deadlines across several projects, each with unique requirements

• Advanced English and native Italian

You are dynamic. You are curious. You are more than your job. For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we're looking for.

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Job Description

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Home-Based in the United States

Responsibilities:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Review listings for coded events to verify Medical Dictionary for Regulatory activities
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance.

Qualifications

• Medical Doctor degree required
• US Board Certification in Nephrology required
• Experience as a practicing Nephrology (minimum of 10 years)
• Full working proficiency in English
• Clinical Research experience preferred
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

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Job Description

This position is open to those based in the San Francisco Bay Area. 

In this position, you will, 

• Actively prospect and leverage potential new business opportunities within specified Customer/Accounts.
• Cultivate strong, long-term relationships with key decision-makers within the Account and develop deep knowledge of the Customer/Account organization.
• Analyze potential opportunities and develop detailed business plans and sales strategies for each Customer/Account. 
• Identify and respond to Customer/Account needs in order to define potential PSI opportunities.  Ensure appropriate strategy/solution is proposed to Customer/Account.
• Work with Operations to identify sales team and prepare presentation.  Educate team participants in Customer/Account culture, operational needs/methods and sales techniques needed to close the sale.
• Lead the entire sales process, including identifying the appropriate team for pitch and preparing and leading the sales presentation.
• Coordinate with the Proposal Development Group to develop proposal and Operations to finalize strategy and pricing.
• Handle follow-up related to the sales and facilitate completion of contractual documents.
• Ensure appropriate hand-off to project team by transferring knowledge on Customer/Account needs and expectations.
• Share Customer/Account strategies and sales plans with Project Directors/Managers.
• Coordinate with Project Managers/Directors and Operations to escalate and quickly address Customer/Account issues/concerns.
• Seek input from Project Managers/Directors to proactively address Change in Scope, new opportunities or customer dissatisfaction.
• Work with Project Manager/Director and Operations to ensure Changes in Scope (CIS’s) are appropriately negotiated with the Customer/Account.
• Maintain high visibility within Customer/Account organization.
• Monitor Customer satisfaction through regular formal and informal surveys.
• Coordinate with Project Managers/Directors to ensure Customer/Account needs are being met and address concerns/issues in a timely manner.
• Review proposals and analyzes requests for proposals and protocols.
• Attend industry events, set up meetings at events, and perform follow-up with potential clients.
• Act as a liaison between Bay Area clients and Operations on an as needed basis.

Salary Range: $100K - $500K 

Qualifications

• University degree in health sciences or an equivalent combination of education, training & experience.
• Demonstrable competency in sales or business development preferably for a Contract Research Organization or company providing services to the healthcare industry.
• 3 - 5 years of business development experience in the CRO sales arena.
• Working proficiency with Salesforce.
• Strong communication, collaboration, problem solving, and time management skills.
• Capable and willing to travel.

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Job Description

• Coordinates investigator/ site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process, including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits. 
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review, management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum of 5 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor. 
• Experience with all types of monitoring visits in Phase II and/or III.
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. 
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Excellent Communication, collaboration, and problem-solving skills.
• Ability to travel up to 65% (depending on project needs).
• Valid driver’s license (if applicable).

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Job Description

The Global Marketing Manager - Europe will help lead the marketing vision, strategy, and development for PSI CRO, championing the brand through digital, traditional, and experiential efforts. They will help connect sales efforts with digital intelligence, collaborate on employment branding, and help direct new efforts toward communicating our company’s unique culture and narrative across the globe.

This dynamic role will report directly to the Senior Director of Global Marketing and be a part of regional and some global Marketing elements within the department: internal, external, sales, and client-facing work. A fast-paced position, it requires excellent interpersonal skills, the ability to think on your feet, and a deep well of new ideas. This rapidly growing team functions as an agency within the company, and has both internal and external clients, so it’s essential that the right fit is comfortable wearing many hats but simultaneously understands both their own values and the company’s culture.

Remote-based in France

RESPONSIBILITIES

• Oversee global account-based marketing and strategy
• Work closely with Business Development on sales support initiatives in Europe
• Manage and maintain PR contacts in industry/paid advertisements/placements in Europe
• Help develop content marketing strategy in support of sales and marketing
• Prioritize engagement with key audiences – KOLs, patients, prospective clients, clients
• Ensure industry and GDPR compliance across all digital channels with web development
• Maintain high attention to detail to ensure accuracy and consistency among all content
• Perform market research (both real-time and traditional) on a regular basis in region and globally

Qualifications

• Bachelor’s degree in communication, journalism, PR, marketing, or related field
• Experience in CRO Marketing and other regulated industry like finance, education, etc.
• Digital management experience
• Experience in a global or cross-regional role
• Effective third-party vendor management experience or experience working in an agency
• Event planning experience is a plus
• Branding experience is a plus
• Strong writing and editing experience, outstanding verbal communication skills
• Executive presence and ability to deliver presentations in small and large groups at all organizational levels
• Capable of managing multiple projects at once with high attention to detail
• Strategic and knowledgeable about digital marketing, advertising regulations within different countries
• Comfortable in a dynamic, fast-paced environment
• Proficient in English

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Job Description

The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects. 

 Communication

• Primary communication point for project teams and company departments with regard to clinical data management
• Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting

 Data Management

• Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables. 
• Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
  • Study documents review
  • Data Management plan and other project-specific guidelines and instructions development and review
  • Co-ordinate/perform user acceptance testing
  • Development of Data Validation Plan/Edit Check Specifications
  • Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues
  • Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
  • Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
  • Database edits (paper CRF studies)
  • Manual CRF review (non-medical checks)
  • Clinical database lock
  • Coordination and supervision of processing, dispatch and archiving of CRFs/queries
• Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
• Development of CRF completion guidelines
• Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
• SAE reconciliation
•  Electronic data transfer (import/export) specifications review and approval

Document Management

• Liaison with Document Center with regard to maintenance of TMF and eTMF

Quality Control

• Database QC checks performance and documentation
• Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
• Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management

Training

• Training of Assistant Data Managers
• Project-specific training of investigators and clinical team in CRF completion

Corporate/Departmental Assignments

• Investigator Meetings preparation/attendance
• Meetings and teleconferences organized by client/vendor preparation/attendance

Qualifications

• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
• At least 3 years of experience of full scope of data management responsibilities in international EDC studies
• At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
• Project data management experience is a plus
• Full working proficiency in English
• Organizational and managerial skills

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Job Description

Please submit your CV in English

You will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries.

You will:

• Develop analysis data sets structure
• Develop program requirements and specifications
• Be involved in SAS programming of ADS and Tables, Listings and Figures
• Support SAS program validations
• Prepare and review  program documentation
• Produce TFL
• Communicate with project teams and company departments with regard to statistical programming of clinical research projects

Qualifications

• University and master's degree in applied science, mathematics, statistics or the like
• Knowledge of SAS software (SAS BASE/SAS STAT/SAS GRAPH) and experience of work in SAS system
• Good knowledge of programming logic, SQL and macro programming is preferred
• Proficient in English, spoken and written
• Experience within clinical trials and/or Biostatistics
• Good analytical skills
• Proficiency in standard MS Office applications
• Excellent communication and interpersonal skills

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Job Description

Resource Management and Training:

• Participation in QM resource allocation
• Resource allocation of QA auditors
• Facilitation of professional development and career advancement of Quality Management staff
• Administrative supervision of Quality Management staff, jointly with Senior Director Quality Management
• Participation in recruitment of Quality Management (QM) staff
• Facilitation of initial and ongoing training of Quality Management staff
• Oversight of initial and ongoing training of PSI Operations employees in quality management topics

Quality Management:

• Facilitation of regulatory agency inspections of PSI
• Facilitation of regulatory agency inspections of PSI-managed trial sites, including follow-up
• Participation in hosting client/third party audits of PSI, including follow-up
• Oversight of CAPA investigations management
• Management of investigations of suspected research misconduct, jointly with Senior Director Quality Management
• Backup responsibility for review of draft Quality Systems Documents (QSDs), including newly developed and revised QSDs
• Backup responsibility for approval of Quality Systems Documents
• Oversight of vendor qualification
• Oversight of computer systems validation documentation review
• Oversight of the process of providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM matters
• May act as the primary QM contact for PSI Operations divisions and working groups/task forces with regard to various Corporate projects requiring QM

Quality Assurance Auditing:

• Development and implementation of the annual audit plan
• Management of QA audits contracted to PSI
• Oversight of the preparation and maintenance of internal and contracted quality assurance audits documentation

Business Development:

• May be recruited by Business Development for client meetings and vendor shows

Qualifications

• College or university degree
• MD, PharmD or degree in life sciences is a plus
• Minimum 7 years of experience in Clinical Research
• Minimum 5 years of industry experience in the capacity of a QA auditor or equivalent
• Must have experience in planning, conducting and reporting all types of quality assurance audits
• Auditing experience in USA
• Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
• Team oriented with superior communication and interpersonal skills 
• Strong time management, organizational, planning and presentation skills
• Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
• Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)
• Must be a reasonably effective public speaker

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