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. #J-18808-Ljbffr