Clinical Trial Manager

Job Description

Manage external vendors and contract research organizations for clinical trials. Assist in the development of protocols and completion of study reports. Plan and participate in meetings with investigators. Maintain the trial master file, ensuring all documents are accurate and up-to-date. Support the progress of clinical trials through effective coordination and documentation.

Qualifications

1. Manage individual clinical trials and programs. 2. Prepare essential study documents such as the Monitoring Manual and Study Operations Manual. 3. Coordinate the design of study materials including CRFs and patient diaries. 4. Ensure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. 5. Provide guidance and support to Clinical Research Associates (CRAs). 6. Track patient enrollment and manage all closeout activities. 7. Negotiate contracts with vendors providing clinical trial services. 8. Guarantee regulatory compliance of all investigational sites involved in the trials.

Benefits

- Health insurance coverage. - Flexible work arrangement options. - Professional development opportunities to enhance your career.