Clinical Trial Leader - FSP

The CTL provides leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s. They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi-country or regional basis. The CTL is responsible for managing the planning, implementation and tracking of the clinical trial processes as well as risk mitigation. The CTL serves as a proactive member of the Clinical delivery team, liaising closely with the CTM on all study related issues, as Lead of the Trial team the CTL communicates trial status to all shareholders.

Accountabilities

• Trial Preparation: Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring). Verifies and provides input into the country allocation and oversees trial feasibility. Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation. Leads development of core trial and patient facing documents. Integrates patient site level feedback during document development and ensures trials are designed with a focus on patient value. Ensures activities are front loaded where possible at the trial level and cascaded to country level to facilitate efficiencies as well as to ensure leverage and speed. Oversees outsourcing of vendor services in conjunction with other functions. Supports identification of vendors, vendor selection and development of vendor scope of work. Works with functional partners to ensure that all required trial processes are in place to meet trial delivery milestones (e.g. clinical quality monitoring, safety monitoring and reporting, investigational medicinal product, trial budget, site monitoring). Aligns and supports team members in timely responses to questions from the RA/EC and other external stakeholders. Provides/supports provision of appropriate study specific and standardized non-trial specific trial team training, internal and external partners.
• Trial Conduct: Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting. Prepare and implement amendments of core documents, including training material updates/retraining as needed. Support authority/ethics response to requests as applicable. Maintain oversight of outsourcing of vendor services (including Central Lab) in conjunction with other functions. Monitors progress of patient recruitment and accrual of endpoints and proactively update and action contingencies throughout trial conduct. For early clinical trials, coordinates and harmonizes innovation unit tasks in trial (e.g. biomarker sampling, genomics, sub-studies).
• Trial Closeout and Reporting: In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports trial medical writer in providing the CTR. Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors. Support results/documents disclosure of global registries. May support publication of trial data.

Expertise required:

• Strong clinical trial project management experience.
• In depth understanding of project management with an emphasis on teamwork, to promote high performance teams.
• Experience in either Oncology, CNS, Immunology or Vaccines.
• Extensive experience in clinical trial project management across international trials.
• Masters Degree ideal but not essential.