Hologic is seeking a Clinical Research Scientist responsible for scientific support of new or on-going clinical trials.
Duties & Responsibilities:
- Responsible for design of clinical studies with the appropriate hypotheses and methods to ensure scientific integrity in accordance with current regulations and guidelines.
- Work with the medical writing team to develop background and discussion language for regulatory documents, including researching and writing.
- Critically review regulatory documents including clinical plans, pre-submission documents, clinical study protocols and reports, integrated summaries, labeling, responses to FDA and other regulatory agency.
- Work with team members to ensure scientific integrity of data by assisting in the development of data collection/review/analysis materials (e.g., CRFs, statistical analysis plans).
- Provide scientific guidance to team members while study is active and review data to identify and investigate discrepant results or issues.
- Assist in training project staff.