This is a great opportunity to work with a world-renowned oncology research and development team to lead GLOBAL studies from early through late phase. On site in GTA office preferred / some remote OK.
- Great company - leader in the field
- Lots of room to move up
- Interesting projects
- Interaction with people all over the world
- Bonus, great benefits, RRSP contribution, etc.
ROLE AND RESPONSIBILITIES:
- Leading a cross-functional clinical study team from onset of study specifications to study archiving.
- Help team deliver studies or projects, meeting time, budget, quality, following ICH/GCP and company SOPs.
- Serve as contact for CRO project manager to ensure work outsourced to CRO follows company guidelines.
- Keep global study plans up to date.
- Study budgets.
- Risk and contingency planning.
- Development of critical study level documents, such as Clinical Study Protocol.
- Select and lead vendors.
- Training for local and site teams and participating in monitoring and investigators meetings.
- Keep studies ready for inspection and meeting ICH-GCP and company SOPs.
- Main point of contact re audit re Trial Master File TMF.
- Adverse events collection.
- BS, B.Sc., MS, M.Sc., PhD biological sciences. PMP nice to have.
- Background in oncology trials.
- Min 7 years of relevant clinical experience in the pharmaceutical or CRO industry leading global trials.
- Great grasp of study management and clinical operations, phases of development, and therapy areas.
- Min 5 years global clinical project management experience.
- Cross-functional team leadership, budgets.
- Strong communication skills, able to build positive relationships, and vendor leadership skills.