Clinical Trial Manager (Phase 3)

Role Summary

The Clinical Trial Manager is responsible for the execution of phase 3 clinical studies and data collection. The incumbent reviews, monitors, and adheres to protocols, as well as fulfilling activities related to study completion. The Clinical Trial Manager will interact internally and externally, and with members of a cross-functional study team.

Responsibilities

• Provide oversight of late-phase clinical research studies across all functional areas of the drug development process.
• Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
• Develop the subject recruitment/retention strategy and related initiatives.
• Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents, including review of site regulatory documents/packages and obtaining of appropriate site insurance.
• Development of training materials for study team, investigational sites, and vendors.
• Proactive management of information sharing with key stakeholders using standardized reports and other mechanisms.
• Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate.
• Oversee preparation of RFPs and prepares bid templates to facilitate selection of the CROs/vendors.
• Collaborate with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed.
• Acts as liaison with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed
• Perform study risk management and implement mitigations.
• Identify potential study issues and recommend and implement solutions or corrective actions as needed.
• Create realistic plans that clearly define goals, milestones, responsibilities and results.
• Maintain focus on strategic objectives while accomplishing operational goals
• Make timely, data-driven decisions.

Qualifications

• Bachelor‚Äôs degree required with 7 years of experience of prior clinical operations experience preferably with CRO/small biotech experience.
• 2 years in a supervisory role.
• Must be able to travel up to 25% of time, may be higher in accordance with project requirements.
• Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IXRS and EDC systems.
• Excellent understanding of drug development process.
• Able to make appropriate decisions to move the project(s) forward.
• Effective verbal and written communication skills.
• Data flow from sites to data processing, review, and resolution.
• Analysis and report generation.
• FDA regulatory requirements (i.e. GCPs, CFRs, etc.). Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
• Study initiation procedures.
• Ability to exercise judgment and determine appropriate action.

Education

• Bachelor‚Äôs degree required with 7 years of experience of prior clinical operations experience (already listed under Qualifications).

Additional Requirements

• Travel up to 5% of time.
• Physical Demands and Work Environment: Sit at desk for long periods; some walking and lifting up to 25 lbs may be required.