It is a great time to join the Genocea team. We are looking for a Clinical Trial Manager who will share their knowledge of expertise and grow with us. The ideal candidate will bring their strategic planning and implementation experience to ensure consistent quality and excellence in the conduct of complex clinical trials. We would like a candidate passionate and not afraid to challenge current practices, decision or ideas to uphold quality standards. Candidates should be imaginative with an entrepreneurial attitude who are comfortable pioneering new methods and tools while partnering with key internal and external stakeholders to develop a vision for executing quality clinical trials.
- Candidate will have experience in managing all aspects of study progress from start-up to close-out activities to assure adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, GCP, and ICH guidelines.
- Candidate will have experience in coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, informed consent development, study drug and clinical supply ordering and management, development of contracts and budgets, clinical study manuals (ie, Study Operations Manual, Pharmacy Manual)
- Candidate will have experience in management of CRO to ensure successful conduct of clinical trials by managing daily study activities to ensure data integrity and quality including co-monitoring visits
- Participates in process of selecting sites for clinical trials on investigational new drugs: assures patient eligibility, communicates and documents protocol violations, reviews and updates site-specific consent forms and documents site progress via standard reports
- Track and report against clinical timelines.
- Accountable for the development of study related documents, including study protocols.
- May travel to field sites to supervise and coordinate clinical studies.
- Participate in and conduct visits and meetings with investigative sites, physicians and consultants, as needed.
- Establish working relationships as appropriate with KOLs/physicians, their research staff, on a regular basis to ensure compliance with protocol and overall clinical objectives.
Cross Functional Management
- Participates in or leads clinical trial team meetings as appropriate
- Responsible for achieving study objectives by working with team members to set project priorities and milestones and resolve project conflicts
- Candidate will be expected to collaborate with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team
- Author or co-author and review Standard Operating Procedures
Contracts and Fiscal Management
- Assist in vendor contract finalization, manage and review invoices for payment
- Identify potential out of scope contractual issues and work with internal team members to resolve issues including finance approval and updates to contract
- Develop and review study site contracts and budgets
- Bachelor Degree in health or biologic science (BS/BA/BScN or higher) is required; masters-level degree is preferred
- A minimum of 5 years’ clinical study management experience in biopharmaceutical industry, preferably with a sponsor company, including a minimum of 2 years as a clinical study lead / project manager; global clinical trial experience is preferred
- Experience in study project management and prior management of contracted resources/CROs is required; site monitoring and clinical quality compliance experience are preferred
- Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials is required; international clinical trial experience and knowledge of other country regulatory requirements is preferred
- Detailed knowledge of MS computer packages and project management software or tools.