Clinical Rsch ProgProj Mgr
Clinical Rsch ProgProj Mgr
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Job Description
GENERAL OVERVIEW
The Clinical Research Program Manager plays a key role in the day to day administration of the translational research activities of the Tearney Laboratory. The Tearney laboratory is dedicated to advance innovative medical imaging device development from research to proofofconcept human studies to multi center clinical trials. The clinical and regulatory team in the Tearney laboratory oversees the development and translation process implements documentation and quality controls and is responsible for all regulatory filings with FDA and IRB. The clinical research project manager takes overall responsibility for the creation and maintenance of all quality control documentation.
DUTIES AND RESPONSIBILITIES
Work closely with the Principal Investigator to implement a quality control system related to all activities of the clinical and regulatory program.
- Map organize and implement a documentation system for each device development project in the Tearney laboratory. Writes operations manuals. Edits manuscripts.
- For each device developed in the Tearney lab prepare a design development plan document that includes device control device fabrication and clinical usage. Assume overall responsibility for the preparation of documentation templates and document control.
- Ensure that all aspects of adherence to all rules and regulations set by the institution the granting agencies and the FDA are complied with at all times through provision of ongoing SOP development and training.
- Oversee maintenance of QC/QA documentation efforts.
- Prepare related reports and work with PI on oversight of QA program compliance.
SKILLS/ABILITIES/COMPETENCIES
Must be able to function independently and make effective decisions.
Must demonstrate excellent judgment and aptitude in problem solving.
Must have strong organizational administrative and time management skills.
Must have excellent oral and written communication skills as well as interpersonal skills with ability to interact professionally at all levels.
Ability to work both independently and as part of a team is essential.
Must have strong database management and computer skills
WORKING ENVIRONMENT
The clinical research manager administrative tasks will take place on the 6th floor of Bartlett Hall at the MGH.
- A BS/BA is required for this position. A MA/MS/MPH is preferred.
- A minimum of 5 years of experience in research/healthcare is required.
Required Experience:
Manager
Employment Type
Part-Time
