Clinical Research Manager
Proclinical is currently recruiting for a Clinical Research Manager with a pharmaceutical company located in New Haven, CT.
- Reviews contract, protocol, and Case Report Forms (CRF's) to assist in the development of the scope of the project
- Requests project team resourcing, including members of the Medical, Data Management, Regulatory, Monitoring and Clinical Supplies departments as needed
- Coordinates and maintains the history of the project, the objectives of the current phase of the project, the strategies planned to reach the objectives, and directs revisions as necessary
- Assures that all project tasks are performed per SOPs
- Coordinates communication with and within all departments regarding the delegation of study tasks and team(s)
- Provides direction for study issues resolution
- Coordinates communication with management and fiscal personnel to ensure ongoing budget compliance through project completion, to ensure the completion of site budgets and contracts, and to ensure funder invoicing and CRA/monitor reimbursement as needed
- Provides oversight for the collection and quality assurance of all regulatory documentation
- Communicates effectively with the site's designated clinical research associate to ensure that the clinical research studies are conducted in accordance with the applicable protocol, FDA regulations and GCP guidelines
- Facilitates communications between funders, CRAs, monitors, and sites to ensure that all protocol amendments, revisions to the Investigator's Brochure and/or significant new adverse effects or risks with respect to study drugs are distributed to all participating sites
- Provides information for proposals for new contract bids, including projected resource allocation for project management time, number of monitors, and monitoring time
Skills and Requirements:
- A minimum of five (5) years strong health care related background with prior oncology clinical and/or data services experience is required.
- 3 years of prior project management experience is required.
- A bachelor's degree from an accredited college or university or a graduate of an accredited school of nursing or possess relevant professional experience is
- SOCRA certification is a plus.
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.