Sr. Clinical Trial Manager
Salary: $160,000-190,000 + Full and Comprehensive Benefits Program
A rapidly growing and innovative biotechnology company focused on developing cutting-edge therapies to combat various forms of cancer is looking to add a Senior Clinical Trial Manager that will play a critical role in managing clinical trial/ study teams. This company is driven by a deep commitment to making a significant impact on patients' lives, leveraging innovative research and development to address unmet medical needs in the field of oncology. While the company is growing internationally, they recognizes that its growth and success are driven by its dedicated team of professionals. To attract and retain top talent, they offer competitive compensation, professional development opportunities, and a supportive work-life balance.
Position Overview
We are looking for a talented Sr. Clinical Trial Manager to join our industry leading organization to take charge as a leader and manage the planning, execution, and completion of clinical trials. They will collaborate closely with cross-functional teams, including clinical operations, data management, regulatory affairs, and medical personnel, to ensure successful trial conduct. As a Sr. Clinical Trial Manager you will demonstrate your understanding the of regulatory requirements, timelines, and budgets while maintaining the highest ethical and safety standards.
Responsibilities
- Lead the cross functional clinical study team(s) including vendors clinical monitors, and clinical sites throughout the life cycle of a clinical trial.
- Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and company SOPs.
- Manage and oversee activities at the CRO and other study vendors, working closely with them; monitor status and provide real-time updates to program team.
- Provide leadership to the clinical operations team working on the assigned program.
- Drafts and coordinates review of relevant documents which includes protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports.
- 15-25% travel with this role.
An ideal candidate will have the following qualifications...
- B.S./ B.A. in biological sciences or equivalent related experience
- 5+ years of relevant industry experience
- Demonstrated knowledge of FDA, ICH and GCP regulations and guidelines
- Experience in leading teams, including CROs, consultants and vendors.
- Ability to deal with time demands, incomplete information or unexpected events
- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
