Senior Clinical Trial Manager

Meet Life Sciences is supporting an emerging biopharmaceutical company in the search for a Senior Clinical Trial Manager. This is a newly created position that will play an important role in the planning and execution of early-stage clinical trials within rare diseases.





About the Role





The Senior Clinical Trial Manager will provide hands-on leadership across clinical study activities, working closely with internal cross-functional partners, CROs, investigative sites, and external vendors. This opportunity is well suited for someone who thrives in a growing biotech environment and is comfortable balancing strategic oversight with detailed trial execution.





Responsibilities






- Lead the operational planning and execution of early-stage clinical trials from study start-up through database lock and closeout.
- Develop and manage study timelines, budgets, enrollment plans, risk-management strategies, and operational deliverables.
- Provide sponsor oversight of CROs, clinical vendors, central laboratories, and other external partners.
- Lead site feasibility, selection, activation, enrollment, monitoring, and closeout activities.
- Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Clinical Supply, and other internal functions.
- Coordinate the development, review, and maintenance of study plans, operational documents, and trial-related materials.
- Track study performance, identify operational risks, and implement mitigation and escalation plans.
- Oversee patient recruitment and retention strategies, with consideration for the unique challenges associated with rare-disease trials.
- Ensure clinical studies are conducted in accordance with study protocols, ICH-GCP, applicable regulations, and company procedures.
- Support the preparation and execution of investigator meetings, site-initiation visits, and internal study-team meetings.
- Review study data, monitoring reports, protocol deviations, and enrollment metrics to support quality and timely execution.
- Contribute to the continued development of clinical operations processes, systems, and best practices as the organization grows.
- Support clinical development planning and future study preparation as needed.






Qualifications






- Bachelor’s degree in a scientific, healthcare, or related discipline; advanced degree is preferred.
- Approximately 7 or more years of clinical research experience within biotechnology, pharmaceutical, or CRO environments.
- Demonstrated experience independently managing clinical trials at the sponsor level.
- Direct experience supporting early-stage clinical development, ideally Phase I or Phase I/II studies.
- Rare-disease or orphan-drug clinical trial experience is strongly preferred.
- Strong knowledge of clinical study start-up, site management, vendor oversight, enrollment, and study closeout.
- Experience managing CROs, budgets, timelines, and multiple external vendors.
- Working knowledge of ICH-GCP, FDA regulations, and global clinical research requirements.
- Ability to operate effectively in a fast-paced, growing organization with evolving priorities.
- Strong organizational, communication, problem-solving, and cross-functional leadership skills.
- Willingness to travel periodically based on study needs.
- Ability to work onsite in Redwood City three days per week.






Required Skills






- Strong knowledge of clinical study start-up, site management, vendor oversight, enrollment, and study closeout.
- Experience managing CROs, budgets, timelines, and multiple external vendors.
- Working knowledge of ICH-GCP, FDA regulations, and global clinical research requirements.






Preferred Skills






- Rare-disease or orphan-drug clinical trial experience is strongly preferred.