Senior Clinical Trial Manager
About The Position
MBX Biosciences is seeking an experienced and highly motivated Senior Clinical Trial Manager (Sr. CTM) to lead the operational execution of clinical studies across one or more development programs. The Sr. CTM will serve as the primary operational lead for assigned trials and will be responsible for managing study conduct from startup through closeout while ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), company SOPs, and timelines. The ideal candidate is a proactive problem solver with strong cross-functional leadership skills, experience managing global and/or multicenter clinical trials, and a passion for driving operational excellence in a fast-paced biotech environment.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- Minimum of 8 years of clinical research experience, including at least 3 years in a Clinical Trial Manager or equivalent leadership role.
- Experience managing Phase II and/or Phase III clinical trials in the biotechnology or pharmaceutical industry.
- Experience leading CROs and external clinical vendors.
- Strong understanding of ICH-GCP, FDA regulations, and global clinical trial conduct.
Nice To Haves
- Advanced degree (MS, MPH, PharmD, or equivalent) preferred.
- Experience in endocrinology, rare disease, metabolic disease, or related therapeutic areas.
- Experience supporting NDA/BLA-enabling studies preferred.
- Experience in a growth-stage biotechnology environment.
Responsibilities
- Lead day-to-day operational management of Phase II and Phase III clinical trials from study startup through database lock and study closeout.
- Serve as the primary clinical operations lead for assigned studies and provide regular updates to leadership and study teams.
- Develop and maintain study timelines, enrollment projections, risk management plans, and operational metrics.
- Identify, escalate, and resolve study-related issues while proactively mitigating risks to trial execution.
- Oversee CROs and external vendors to ensure adherence to scope, timelines, quality expectations, and budget.
- Lead vendor selection, qualification, oversight, and performance management activities.
- Review vendor deliverables and monitor key performance indicators to ensure study milestones are met.
- Partner with vendors to drive operational efficiencies and continuous improvement.
- Collaborate closely with Clinical Development, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Pharmacovigilance, Clinical Supply, Quality Assurance, and other functional areas.
- Lead cross-functional study team meetings and ensure alignment across stakeholders.
- Contribute to study planning, protocol development, investigator meetings, and operational strategy discussions.
- Support site feasibility, site selection, activation, enrollment, retention, and closeout activities.
- Review monitoring reports and study metrics to identify trends and areas requiring intervention.
- Ensure appropriate oversight of site performance, data quality, and protocol compliance.
- Ensure studies are conducted in compliance with ICH-GCP guidelines, applicable regulations, company SOPs, and protocol requirements.
- Support inspection readiness activities and participate in audits and regulatory inspections as needed.
- Review study documents, trial master file metrics, and quality indicators to ensure regulatory compliance.
- Assist in development and management of clinical trial budgets and forecasts.
- Review vendor invoices and provide budget oversight throughout the study lifecycle.
- Monitor study expenditures and communicate potential budget risks.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
