Clinical Trial Manager

Position Summary:

The Clinical Trial Manager is responsible for managing the execution of clinical studies and data collection. The incumbent oversees the review, monitoring and adherence to clinical protocols, as well as fulfilling activities related to study completion. The Clinical Trial Manager will interact internally and externally with members of the cross-functional study team.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide oversight of 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, and/or supervision of team members performing these activities.
• 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 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 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.
• Manage daily activities, assign tasks, goals, and development of direct reports.
• Other duties as assigned.

Education and Experience:

Required:

• Bachelor’s degree required, preferably in scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered.
• Minimum of 7 years of prior clinical operations experience preferably with CRO/small biotech experience and 2 years of experience in a supervisory role. Experience in early phase studies is preferred.
• Must be able to travel up to 5% of time, may be higher in accordance with project requirements.
• Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, document repository, CTMS, IRT, 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, report generation, and presentation to broader teams as needed.
• 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.

Preferred:

• Prior experience in the planning and conduct of early phase clinical trials

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential funct