Senior Medical Affairs Operations Manager

Role Summary

The Senior Medical Affairs Operations Manager is responsible for managing the execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies and post-trial access programs. The incumbent oversees the review, monitoring, and adherence to clinical protocols, taking ownership of key projects and working independently. The Senior Manager, Medical Affairs Operations, will interact internally and externally with members of the cross-functional study team and may supervise more junior managers and/or assistants as required.

Responsibilities

• Provide oversight of clinical affairs programs across all functional areas of the drug development process, including post-trial access programs coordinating the continued provision of investigational product to participants, in accordance with regional regulations.
• Provide operational and strategic input into planning for expanded access programs and study specific documents such as synopses, protocols, ICFs, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plans, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
• Coordinate and lead study team meetings and provide key stakeholders with updates on program progress including timelines, budget, and key milestones for the program.
• Develop the subject recruitment/retention strategy and related initiatives.
• Oversee 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, and/or supervision of team members performing these activities.
• Develop training materials for the program team, investigational sites, and vendors.
• Manage information proactively by sharing with key stakeholders using standardized reports and other mechanisms.
• Assure programs are compliant with ICH/GCP and other regulations as appropriate.
• Oversee preparation of RFPs and prepare bid templates to facilitate selection of the CROs/vendors, and/or collaboration/supervision with team members performing these activities.
• Collaborate with counsel to negotiate and draft contracts and agreements with CROs/vendors and clinical sites, as needed.
• Act as liaison with Regulatory Affairs to assure adherence to GCPs, conduct maintenance of SOPs, and ensure site and CRO/vendor audits are completed.
• Perform study risk management and implement mitigations.
• Identify potential program 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

• Minimum of 8 years of prior clinical operations experience managing clinical trials, preferably with CRO/small biotech experience; at least 5 years in a supervisory role. Experience managing clinical studies is preferred.
• Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, and IRT and EDC systems.
• Excellent understanding of the drug development process.
• Able to make appropriate decisions to move the project(s) forward.
• Effective verbal and written communication skills.
• Experience handling data flow from sites to data processing, review, and resolution.
• Strong ability to analyze and generate reports.
• Understanding of FDA regulatory requirements (i.e. GCPs, CFRs, etc.).
• The ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
• Experience with study initiation procedures.
• Ability to exercise judgment and determine appropriate action.
• Experience in rare disease and/or oncology is preferred.

Education

• Bachelor’s degree required, preferably in a scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered.

Additional Requirements

• Travel: You may be required to travel for up to 10% of your time.
• Physical Demands: On a continuous basis, sit at a desk for long periods; intermittently answer telephone and use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs may be required.
• Laboratory Activities: Biology and chemical laboratory environment experience may be needed. Environmental health and safety requirements also apply.