Ref #: 36630

Employment type: Permanent - Full-Time

Location: Home based in Europe

Posted: 20-May-2022


Clinical Trial Managers (m/f/d) provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL). This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities Work closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. Ensure inspection readiness. Takes ownership for assigned responsibilities. Demonstrated competency to act as a backup or first point of contact in absence of the GCDO Trial Leader. Advanced is given assignments that are more complex and/or have a greater potential impact on business results. May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input. May contribute to process improvement and/or non-project work.

Key Responsibilities:
• Lead the Study Management Team.
• Ensure availability of required reports
• Manage timely and accurate documentation and communication of trial progress
• Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
• Act as primary contact for Country and Regional staff.
• Act as the primary contact person for the local teams within GCDO.
• Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.
• Ensure issue escalation and drive issue resolution.
• Ensure the availability of robust recruitment/contingency plans are in place for each region.
• Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
• Perform Annual Quality Review of files, as appropriate.
• Establish country budgets and monitor actuals vs. forecast
• Oversight of selected vendors and status of related deliverables.
• Monitor budgets and expenditures as expected per planned trial budget.
• Create and update trial-specific documents as required;
• Provide input into cross functional documents
• Responsible for the set-up, coordination, attendance participation of Investigator Meetings.
• Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
• Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
• Participate in preparation for, and conduct of, Health Authority inspections and internal audits.

Job Requirements:
• BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Clinical trial management experience in the pharmaceutical industry or CRO.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
• Demonstrated effective leadership
• Strong project planning/management.
• Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems.
• Monitoring experience is recommended
• Travel.
• Proficient in speaking and writing local country language and English.

What is offered:

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
• 100% Home based
• Permanent contract
• Great work atmosphere
• Compensatory time-off
• Contribution to pension scheme