Position: Clinical Trials Manager

(Flexion is not accepting resumes for this position from third parties at this time.)

Description:

Flexion is currently seeking a Senior/Clinical Trials Manager.

The Senior/Clinical Trial Manager will independently oversee clinical studies from concept to final close. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical.  The ideal candidate will be highly adaptable and a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables.

Job Responsibilities:

• Participate in the selection and management of contract research organizations (CROs) and other outside vendors to support clinical studies
• Serve as the primary liaison between Flexion and CROs in the execution of outsourced clinical trial functions
• Oversee study activities including: selection of investigators, study start-up activities including site initiation, study monitoring activities and data collection
• Develop and manage study timelines
• Contribute to the development of study related documents (contracts, ICFs, protocols, IBs, etc.)
• Participate in review of CRFs, CRF guidelines, edit check specifications, Statistical Analysis Plans
• Prepare clinical study budgets and track budgets for variances
• Project and track study enrollment and drug supply
• Track and file all critical study documentation
• Provide routine updates to project team on study status/issues

Requirements:

• Requires a BA/BS, RN, or related degree with at least 3-5 years as a CTM with direct management of vendors and CROs
• Experience in clinical operations and/or early clinical development is strongly preferred
• Troubleshooting skills
• Ability to work independently
• Working knowledge of GCP, ICH and relevant CFRs is required
• Project management skills, effective communication (written and verbal), adaptability and self-motivation are required attributes
• Approximately 10% travel, primarily involving travel to conferences, Investigator meetings, or co-monitoring