POSITION: TRANSLATION RESEARCH PROJECT MANAGER
The Translational Research Project Manager has a primary role in ensuring that Invicro preclinical, early phase and chemistry research projects are conducted on time and within budget. This position takes a lead in interfacing with external research partners on a daily basis and is responsible for the operations/logistics of their assigned studies. This position will seek guidance from the Director of Translational Research and Preclinical Oncology team as appropriate.
- Develop study timelines for translation research projects including but not limited to non human primate studies, chemistry manufacturing and controls (CMC) projects and toxicology studies.
- Create, manage and/or participate in the design of study specific project plans and supporting documents such as Gantt charts, technical manuals, source documentation and other study supplies as needed.
- Track and assess study metrics on an ongoing basis. Complete milestone tracking and revenue recognition for translation research projects. Interact closely with the Finance Department in the development and management of study budgets; monitor for scope changes.
- Provide oversight of incoming data; develop strategies for ensuring timely receipt of study data and documents from multiple vendors.
- Work closely with Regulatory, Chemistry, Preclinical and other Invicro functional groups to ensure efficient flow of information.
- Assist in the selection, auditing and qualification of vendors. Manage vendor relationships including material handling, protocol development, report reviews and sponsor coordination.
- Oversee CMC logistics required to submit, acquire and maintain an IND for the clinical imaging studies.
- Organize and hold regularly scheduled project team meetings; generate and maintain agendas/minutes as needed.
- Ensure quality of all results and reports, as well as making sure all study-specific tasks get completed satisfactorily.
- Additional responsibilities to be delegated as deemed necessary by supervisor.
Qualifications and Skills:
- Bachelor’s Degree with 3+ years of experience in a relevant field or Masters Degree
- Working knowledge of oncology and early phase clinical trials
- Trained on and well-versed with FDA rules and regulations, and ICH Good Clinical Practices
- Highly organized with the ability to prioritize and meet deadlines in a fast paced environment
- Ability to demonstrate leadership experience in a team environment
- Excellent communication skills
- Superior time- and project-management skills
- Able to professionally and confidently interact with teammates and subcontractors
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.