Clinical Trial Manager

Position Summary

The Clinical Trial Manager will support the overall management and coordination of operational activities involved in the planning, conduct and completion of clinical trials including the management of deliverables, adherence to budget, and ongoing risk mitigation.

General JOB FUNCTIONS/RESPONSIBILITIES

• Drive the planning, development and execution of timelines, while identifying and tracking the team's critical path.
• Facilitate the project team kick-off meeting by identifying key stakeholders and resources.
• Execute and control project activities, including scope, schedule, budget and risk associated with each assigned project and report performance to senior management.
• Help support the establishment of communication plans for information distribution to team members.
• Support study meetings.
• Support the Clinical Operation’s lead in the reviews at significant milestones or gates to evaluate successes as compared to baseline estimates.
• Identify and track key study metrics to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed).
• Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents.
• Support the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics.
• Help the Clinical Operation Lead in identifying, evaluating, and selecting external vendors (central lab, CROs, consultants/contractors).
• Train and manage CROs and other clinical vendor activities to ensure the quality meets company and regulatory requirements.
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
• Develops/reviews and approves study plans.
• Support the development of contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract.
• Support the identification, selection and proper initiation of sites.
• Help develop patient recruitment strategies to ensure goals are achieved.
• Plan and coordinate investigator meetings.
• Plan, coordinate and conduct Data Monitoring Committee (DSMC) meetings.
• Oversee timely database freeze and database lock.
• Participate in data review meetings.
• Oversee maintenance of the Trial Master File for each study and conduct periodic QC reviews of the TMF to ensure quality.
• Ensure adherence to SOPs, Good Clinical Practice and FDA/ICH regulations.

Qualifications

• Bachelor’s degree or equivalent in the life sciences or related field required.
• Additional coursework or certifications in clinical trial planning and operations desired.
• At least 5 years of relevant experience with project management and clinical development.
• Experience in liver disease is a plus.
• Experience in small, fast-paced biotech is a plus.
• Experience working in a fully outsourced model is a plus.
• Demonstrated experience coordinating interdepartmental activities and efforts to meet protocol and program goals.
• Expert and extensive knowledge of CRO / vendor management and global protocol operations.