Senior Clinical Trial Manager
Salary: $165,000-185,000
Waltham, MA (Hybrid)
A leading biotechnology copmany specializing in immuno-oncology research and development, located in the vibrant biotech hub of Waltham, Massachusetts is seeking to add a Senior Clinical Trial Manager. They are dedicated to discovering and developing innovative therapies to combat cancer by harnessing the power of the immune system. The team htat is dedicated to developmeing transformative therapeies that redine the stanard of care for cancer pateints worldwide
Position Overview:
We are looking for a talented Sr. Clinical Trial Manager to join an industry leading organization to take charge as a leader and manage the planning, execution, and completion of their early phase 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. This position offers an exciting opportunity to contribute to the development of groundbreaking therapies that have the potential to transform the lives of cancer patients. Join this fast growing organization and have the ability to showcase your prowess in navigating the complexities of clinical trials while upholding the utmost standards of safety and ethics.
Responsibilities:
- Lead the planning, implementation, and management of Phase I-III clinical trials for immuno-oncology drug candidates, ensuring compliance with regulatory requirements, ICH-GCP guidelines, and company SOPs.
- Serve as the primary point of contact for clinical trial sites, investigators, and contract research organizations (CROs), providing guidance and support throughout the duration of the trials.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.
- Develop and manage clinical trial timelines, budgets, and resources to ensure timely and cost-effective execution of clinical programs.
- Drafts and coordinates review of relevant documents which includes protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports.
- Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance, to ensure alignment of clinical trial activities with overall development strategies and objectives.
- Lead the preparation and conduct of investigator meetings, site initiation visits, monitoring visits, and close-out visits, ensuring compliance with protocol requirements and study timelines.
- Provide leadership and mentorship to junior members of the clinical operations team.
- Up to 10% travel.
An ideal candidate will have the following qualificationsโฆ
- B.S./ B.A. in biological sciences or equivalent related experience.
- Minimum of 5-7 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- At least 2+ years pf experiance inz oncology or immuno-oncology preferred.
- Proven track record of successfully managing Phase I-III clinical trials from start-up to close-out, including experience with study start-up activities, site management, and data management.
- Strong understanding of clinical trial design, execution, and regulatory requirements, including FDA and EMA regulations, ICH-GCP guidelines, and industry best practices.
- Excellent project management skills, with the ability to effectively prioritize tasks, manage competing priorities, and meet deadlines in a fast-paced environment.
