Summary
The Senior Clinical Trial Manager will lead the day-to-day activities in a clinical trial, and support the program strategy in a highly collaborative environment. The successful candidate will manage members of the clinical operations team, including those at CROs and study vendors, work collaboratively with clinical trial sites, and partner with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in line with regulatory requirements. The successful candidate must be comfortable working independently and cross-functionally to ensure study compliance and data quality.
Responsibilities
Lead cross-functional meetings with the Clinical Development, Clinical Operations, Data Management, regulatory, Quality, and Clinical Supply Chain.
Support the development within budget and on schedule.
Drive study startup activities, including feasibility, site selection, and timelines.
Manage activities of Phase 1 and 2 clinical trial investigators with a focus on the US to ensure compliance with the study protocol and overall clinical objectives.
Maintain clear communication across all departments.
Proactively manage, identify, and mitigate risks with the study team.
Serve as cross-functional lead for the clinical trial.
Identify and report potential program issues and implement CAPAs where necessary.
Act as the primary point of contact for trial execution and escalation.
Provide financial and management accountability updates to internal stakeholders as required.
Lead the oversight of CROs and vendors in partnership with the rest of the Clinical Operations team to assure the integrity of clinical data with respect to accuracy, accountability, and documentation through review of case report forms, source documents, medical records, etc.
Perform clinical research site activities, which can include onsite or remote monitoring, co-monitoring, and training visits.
Ensure that all study documentation and SOPS are maintained according to applicable regulations and industry-accepted standards, both in the field and in-house.
Contribute to the development of study documentation, including protocol review, study operations manuals, SOPs, ICFs, CRFs, CSRs, IBs, and data cleaning.
Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.
Limited travel possible to clinical sites to supervise and/or monitor clinical studies (~25%).
Qualifications & Education
Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
5 to 8 years of experience in clinical operations or direct study management in a biotech or pharmaceutical company (Industry Sponsor).
Excellent communication skills.
Extensive experience managing US clinical sites, including start-up activities and monitoring.
Experience in oncology (preferably in solid tumors); radiopharmaceuticals a plus.
Experience overseeing CROs and vendors, maintaining timelines, and overseeing budgets.
Experience with clinical data review and data management processes.
Excellent communication, organizational, and leadership skills.
Ability to work independently, plan, prioritize, and risk mediate in a fast-paced environment.
Strong working knowledge of GCP, ICH, and FDA regulations.
