Global Trial Manager Pre-Approval Access - Belgium, Netherlands
- The Global Trial Manager Pre-Approval Access is accountable for the successful global or regional execution of Pre-Approval Access Programs assigned by the Functional Manager, Clinical Program Leader or Clinical Operations Head within a Therapeutic Area, within agreed timelines and budget, in alignment with all the applicable SOPs and regulatory requirements.
- This position leads the Pre-Approval Access team and interfaces with the correspondent company Medical Affairs Teams, Clinical Teams, Global Operations Support CoE Teams (GOS), and other Clinical Development Operations (CDO) functions, Regional Trial Coordination/Site Management (TCSM) colleagues, Study Sites (if applicable), and the Research and Development/Operating Company. Alignment of goals with organizational objectives as defined in the GCO cascades.
- Considered the program study owner and Pre-Approval Access Program Lead. Main focus is on program management supervision, planning and coordination, including program set-up, execution, and reporting (includes program closure). Measures program progress against agreed upon timelines to milestones.
- Ensure accurate budget management for assigned programs. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes.
- Monitors patient recruitment at the global level, and ensure timely and accurate documentation and communication of program progress and issue escalation.
- Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the program operates in a constant state of inspection-readiness. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned program utilizing the available tools.
- In coordination with the Clinical Program Leader, Study Responsible Physician (SRP) and/or Clinical Leader, the GTM is responsible to ensure appropriate program-specific training to the appropriate colleagues.
- Ensure deliverables are carried out according to the program plan. Provides updates to appropriate Clinical Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of Program status according to Program plan.
- BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy),
- Minimum of 5 years clinical trial experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Requires clinical research operational knowledge, project planning/management and communication skills,
- Should be flexible and able to manage global or regional teams in a virtual environment.
- Excellent decision-making and strong financial management skills are essential to this position.
- Effective leadership skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required.