Clinical Trial Manager
Cambridge Metro Area, Massachusetts
BS/MS/PhD - Nursing, PharmD, Health, Life Sciences or related discipline and experienced in pharmaceutical clinical trials study management
- Responsible for clinical study protocol development including authoring protocols
- Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.
- Assist to identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meetings.
- Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility.
- Oversee the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
- Chair Clinical Trial tactical meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards.
- Communicate study progress to Management, Project team representatives and others
- Regularly update all trial information databases in order to manage accuracy of information.
- Review and approve all study payments as per financial agreements.
- nteract with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
- Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high quality data are transferred/available in a timely manner.
- Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure report is completed according to current requirement.