Job Description

Fixed Term Contract / Full-time / Remote. Contract length 6-8 months.

You will join an exciting and challenging project to assess the state of PSI internal network infrastructure, share your expertise with our internal IT teams, setup processes and procedures that are required to manage the network successfully, and implement IT infrastructure systems to support PSI business processes and operations. You will work as a part of an international IT team, mentoring engineers to troubleshoot and optimize PSI networks for our users.

You will:  

• Plan, design and implement LAN/WAN/Security solutions that are in line with industry standards and compliance.
• Review, assess, and recommend network standards to support, routing & switching, data centers, cloud-based architectures.
• Evaluate the current state of the network, provide recommendations and implement solution to ensure the network architecture are updated with latest industry best practices.
• Produce High Level Design and Low Level Design documentation for network projects.
• Develop and implement network related processes and procedures, troubleshoot reported errors.
• Optimize and maintain LAN and WAN.
• Optimize and maintain backup and restore processes.
• Translate highly technical specifications into clear non-technical requirements.
• Create IT guidelines and manuals; maintain complete technical documentation.
• Work as coach and mentor for team members, with an intuition for analyzing and solving technical problems.
• Peer review network configuration changes and provide training to empower engineers and operational staff on performing network infrastructure support and maintenance.

Qualifications

• Demonstrated experience as a senior network engineer, network design engineer or architect
• Professional certification (e.g. CCNP, CCSP, CCDP)
• Experience with network diagnostic, logging, monitoring and analysis tools
• In-depth understanding of communication protocols (mainly TCP/IP) and routing protocols (e.g. BGP, OSPF)
• Cloud solution experience is desirable
• Ability to assess business needs and translate them into relevant solutions
• Ability to document and maintain detailed technical documentation and procedures
• Ability to quickly learn new, unfamiliar and emerging technologies
• Organizational and mentoring skills
• Ability to precisely explain complex issues
• University Degree in Computer Science, Engineering, or the like
• Full working proficiency in English

See more jobs at PSI CRO

Apply for this job

Job Description

We looking for a knowledgeable, proactive, and self-motivated Systems Engineer to join our global yet closely-knit Systems Development team.

Full-time employment in Estonia

In this role, you will be involved in evaluation, testing and implementation of IT infrastructure systems to support PSI business processes and operations.

You will:

• Provide support of off-the shelf software packages (Tier 2 and Tier 3)
• Perform installation of Tier 3 and certain Tier 4 information systems and conduct user training
• Perform installation and support of specialized systems (e.g. special warehouse systems)
• Monitor company’s software updates and new software releases and recommend migration to these versions if necessary
• Follow release of new software which can potentially interest the company, and recommend their purchase
• Update validation status of CFR 21 Part 11 applicable to information systems
• Study project-specific IT equipment provided by company’s clients, conduct required user training and provide further equipment support
• Conduct regular technical audits in the company’s departments, to check compliance with PSI standards regarding usage of specialized equipment and Tier 3-4

Qualifications

• University or College degree, IT specialty 
• Solid technical background
• Prior experience in systems administration
• Experience of work with JIRA Service desk and Confluence or similar products
• Full working proficiency in English
• Experience in IT systems development and systems validation is a plus
• Experience with creating SQL queries
• Background in testing (preparing test cases and execution of test scripts) 
• Knowledge of MS Visio
• Excellent communication and collaboration skills
• Strong analytical skills
• Ability and desire to work in a service-oriented and customer-focused environment

See more jobs at PSI CRO

Apply for this job

Job Description

PSI is seeking a Software Development Project Manager with a strong background leading teams in software, UX, reporting, and database development to help us build our next generation global enterprise cloud Data Platform and associated reports, dashboards and applications. In this role, you will lead teams of engineers in an Agile and waterfall environment to deliver a variety of applications, databases, ETL, reporting and web/mobile applications to our internal and external customers that work with or sit on top of our Data Platform.

Please note the official PSI CRO job title will be: Manager, Process Improvement.

Responsibilities

• Developing detailed, well-conceived project development plans, and driving the team to deliver on roadmap commitments.
• Assemble a team of from employees, consultants, etc. to fill the roles to deliver the project on time and of high quality.
• Manage delivery of a complex software project spanning networking, infrastructure, databases, data lakes, engineering, and UX.
• Maintain Project plans and show progress of project from inception to delivery.
• Project manage and drive large cross functional deliverables.
• Setting the roadmap for the service by negotiating requirements and deliverables with product management, various internal and external customers
• Apply your knowledge of software architecture to manage software development tasks associated with developing, debugging, or designing software applications, operating systems and databases according to provided design specifications. You should be able to work effectively in a collaborative and agile environment; and have a hands-on management approach.
• Make critical design decisions with impact across all aspects of the project.
• Build solid and effective relationships with the business, including product management and other engineering leaders, to enable excellent teamwork and development of offerings
• Responsible for driving product development and delivering results in an aggressive and fast paced environment
• Full Stack Development (Front end, middle tier and back end tier) (i.e. Microsoft )
• Knowledge of cloud computing including Azure 
• Manage Azure Cloud projects for the design, implementation and support of new cloud platform architecture and automation technologies, as well as updates and maintenance of existing cloud and automation systems

Qualifications

• 6+ years of experience developing/operating/managing products and/or services, including 3+ years in a management position.
• 8+ years as a full stack developer preferably on a Microsoft Platform
• Extensive experience using Project Management Software like MS Project
• In-depth experience in the management, design, administration, programming, and support of RDBMSs like Microsoft SQL Server
• Deep knowledge leading software development teams to build .Net Windows applications
• Thorough understanding of the relational database model and solid theoretical knowledge of relational database techniques
• Experience in designing, modeling, developing, and supporting large RDBMSs
• Experience delivering reports, dashboards, etc., with BI tools like PowerBI, Tableau, etc.
• Knowledge of project management processes to oversee database development and operations
• Previous experience leading large globally distributed teams
• Demonstrated ability to apply technology solutions to business problems
• High-level analytical capabilities, applied to complex work programs
• Excellent written and verbal communication skills; ability to present offerings to customers and stakeholders
• Ability to deep-dive into architectural and technical discussions
• Excellent written and verbal communication skills with the ability to present complex technical information in a clear and concise manner to a variety of audiences.
• Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced environment.
• Strong Agile skills and proven track record for product delivery.
• Knowledge of various DevOps tools and practices including GitHub, Jira, Confluence and CI/CD
• Excellent time management skills with ability to manage a large, diverse set of to-dos – vigorously prioritize, stay on top of multiple work streams, monitor progress, hold owners accountable.
• Global mindset with ability to think about culture, language, and other aspects when putting the customer at the center of all outcomes.

See more jobs at PSI CRO

Apply for this job

Job Description

As a CRA at PSI you will be involved in improving patients' lives while enjoying a variety of monitoring tasks and working on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

Office-based in Munich/Planegg or Home-based in Germany

You will:

• Conduct and report all types of onsite monitoring visits as well as remote visits.
• Perform CRF review, source document verification and query resolution.
• Be responsible for site communication and management.
• Be involved in site identification process.
• Assist in training of less expert CRAs, depending on your level of experience.

*Senior CRA can be assigned as Lead Monitor in some projects, while still partially monitoring.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience.
• Independent on-site monitoring experience in Germany.
• Independent experience in all types of monitoring visits in AMG studies, Phases II and/or III.
• Experience in Oncology, Hematology, Infectious / Rare / Gastro-intestinal Diseases is a plus.
• Full working proficiency in German, English and MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Communication, collaboration, and problem-solving skills.
• Ability to travel and valid driver’s license.

See more jobs at PSI CRO

Apply for this job

Job Description

• Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
• Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
• Collects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
• Critically assesses, interprets, and summarizes data from clinical studies
• Reviews scientific literature pertinent to medical writing activities
• Performs quality control (QC) reviews of PSI-developed Essential Documents and other documentation (in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing)
• Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
• Collaborates with the Process Improvement narrative automation team to develop patient safety narratives

Qualifications

• College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life sciences fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities.
• Minimum 2 years of corresponding industry experience working with clinical documentation and data
• Prior pharmaceutical, biotechnology, or contract research organization experience
• Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
• Basic knowledge of electronic Common Technical Document (eCTD) requirements

See more jobs at PSI CRO

Apply for this job

Job Description

• Supports the Associate Director Data Governance in defining and developing policies, standards, processes and metrics to support PSI’s Data Governance agenda
• Leads data stewardship working groups to support a data driven culture at PSI
• Maintains and publishes Systems and Data Asset Inventories, Business Glossaries, and Data Lineage documentation
• Identifies opportunities and recommends solutions for improving Data Quality
• Translates business Data Governance challenges into resolutions, develops and supports delivery thereof
• Provides technical support, development, and maintenance of the Informatica Data Governance tools – Axon, Enterprise Data Catalogue (EDC) and Information Data Quality (IDQ)

Qualifications

• Bachelor’s Degree in Computer Science, Information Technology, or related field is a plus
• 2 years’ experience in using and configuring Data Governance Tools required
• Experience in working with and developing Data Stewardship groups
• Proficient in building Business Glossaries
• Proficient in assigning Business Owners and Data Steward workflows
• Ability to link policy and processes required to govern data
• Ability to curate EDC (develop lineage etc.)
• Proficient in development of IDQ Scorecards
• Experience in Informatica MDM and DPM solutions is a plus

See more jobs at PSI CRO

Apply for this job

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.

Office / hybrid in Madrid or Barcelona, or home-based in Spain

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
• Oncology board certification is a must
• Prior and wide experience as a practicing Oncologist (minimum of 10 years)
• Full working proficiency in English
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

See more jobs at PSI CRO

Apply for this job

Job Description

In the role of Sr CRA II (Lead Monitor), you will manage local Monitors, supervising clinical monitoring and site management activities to verify the protection of trial subjects’ rights, safety and well-being, data quality and study compliance on a country/regional level.

Only CVs in English will be considered.

You will:

• Facilitate regional projects as Lead Monitor and supervise study activities, timelines and schedules 
• Train Monitors in annotated monitoring visit reports
• Review monitoring reports and support monitors in their activities
• Act as the main communication line between Monitor and Regional Lead 
• Facilitate site budgets and contract negotiations
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress and lead project team calls on the country level 
• Participate in quality control and compliance monitoring
• May need to monitor and manage sites (if applicable)
• May need to supervise monitors on site
• Oversee and maintain study-specific and corporate tracking systems at site and country level

Qualifications

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• Participation in clinical projects as a Lead/Senior Monitor
• Independent on-site monitoring experience
• Full working proficiency in English and Spanish
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, multitask and work in a dynamic team environment
• Communication, leadership, and problem-solving skills
• Ability to travel

See more jobs at PSI CRO

Apply for this job

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 Canada. 

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
• Canada Board Certification in Gastroenterology required
• Experience as a practicing Gastroenterology (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

See more jobs at PSI CRO

Apply for this job

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 Gastroenterology required
• Experience as a practicing Gastroenterology (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

See more jobs at PSI CRO

Apply for this job

Job Description

Home-based position in Brazil;
Only CVs in English will be considered.

In this position, you will:

• Work closely with departments to maintain Knowledge Management (KM) tools that facilitate centralized knowledge sharing across PSI;
• Participate in application development projects where necessary;
• Maintain Knowledge Management team owned applications;
• Control data governance policy adherence;
• Be responsible for ongoing data cleaning and restructuring activities to ensure quality and accessibility of knowledge assets;
• Be responsible for access control, support, and technical maintenance;
• Provide ongoing support and guidance to staff, ensuring effective utilization of the systems;
• Organize and conduct initial training for SharePoint users and site administrators;
• Support ongoing training for users and site administrators.

Qualifications

• Bachelor's degree or an equivalent combination of education, training and experience;
• Previous experience in knowledge management, training, data management or governance activities in a multi-national company;
• Previous experience with SharePoint and system user support is a plus.

See more jobs at PSI CRO

Apply for this job

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.

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.

See more jobs at PSI CRO

Apply for this job

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).

See more jobs at PSI CRO

Apply for this job

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

See more jobs at PSI CRO

Apply for this job

Job Description

As a Senior CRA (Radiopharmaceuticals) you will participate in the preparation and execution of Phase I-IV oncology clinical trials with particular focus on radiopharmaceutical studies including startup and site monitoring activities to ensure timelines and deliverables are met at assigned sites. You will build and maintain strong relationships with clinical sites and investigators and assess protocol and regulatory compliance in accordance with applicable local and federal regulatory requirements, ICH GCP and PSI SOPs. You will focus on subjects’ rights, safety and well-being and ensure a high quality of data.

Responsibilities include:

• Prepare, conduct and report on activities related to the completion of site selection, initiation, routine monitoring and close-out visits
• Monitor patient enrollment to ensure recruitment targets and project timelines are met at the site and/or country level
• Perform source data verification and follow up on data queries at the site level, on-going review of any Risk Based Monitoring related information influencing data quality and frequency of site visits
• Ensure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations
• Act as the main line of communication between the Sponsor and the site
• Be a point of contact/liaison for in-house support services and vendors
• Ensure proper handling, accountability and reconciliation of all Investigational Product(s) and clinical study supplies
• Review the status and contents of essential documents at the site level and reconcile study OSF/ TMF at site and/or country level

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 3 years’ site monitoring experience.
• Prior experience in Radiopharmaceuticals is required. 
• Strong experience in Oncology required.
• Experience with all types of monitoring visits in Phase II and/or III.
• 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).

See more jobs at PSI CRO

Apply for this job

Job Description

The Lead Data Manager is responsible for all data management activities in assigned clinical trials under supervision.

• Acts as primary communication point for project teams and company departments regarding clinical data management
• Acts as primary communication point for clients/vendors for all data management aspects of clinical projects
• Coordinates 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
• Provides input into monitoring of project scope, budget, timelines, and deliverables
• Is responsible for clinical data management activities including, but not limited to:
  • Development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
  • User acceptance testing
  • User access management
  • Data review
  • eCRF/External data reconciliation
  • Medical coding (for staff with medical/Life Science background)
  • SAE reconciliation
  • Query management
  • Study Database Lock activities
  • Archival of CRFs QC Coordination 
  • Project status reporting
  • Data listings/Patient profiles generation
• Maintains and QCs TMF/eTMF as well as Data Management working files
• Trains Data Managers and Assistant Data Manager
• Conducts project-specific training

Qualifications

• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities 
• Minimum of three years of industry experience in Data Management 
• Two years in Data Manager role
• This role requires travel on an as needed basis for client presentations, bid defense meetings, department meetings, and the like. 

See more jobs at PSI CRO

Apply for this job