160,00 - 175,000
7 months ago
This candidate will be instrumental in supporting my clients clinical program. The candiate will have hands on responsibility with the planning and managment of late stage clinical phases of the ongoing programs. Management of CRO relationships and internal company timelines are key aspects of thsi positinos.
- Responsible for the overall operational setup and execution of specific clinical studies related to our pruritus program from study concept through study completion, while adhering to scope and schedule requirements as per corporate goals
- Manage day-to-day activities associated with the conduct of Phase 3 clinical studies from implementation to study closure
- Manage vendors (ie, selection, negotiation, implementation of work orders and change to work orders) and ensure execution of deliverables within approved clinical trial budget and timelines. Work alongside with program manager
- Provide support in the planning, design, and execution of required documentation in compliance with project plans, federal regulations, and ICH/GCP, such as monitoring plan, study management plan, recruitment materials and so on
- BA/BS/MS degree or equivalent education
- 10+ years in the pharmaceutical or biotech industry with proven experience as a clinical trial manager
- Experience with the conduct and management of both Phase 1, 2 and Phase 3 trials is required with strong emphasis on Phase 3; experience with the conduct of global trials is desirable.
- Ability to travel ~20 % of time