AD, Clinical Project Management; Metabolic)

We are seeking an experienced, highly organized, and collaborative Senior Clinical Trial Manager (Regional CTM) as a professional who oversees and manages clinical trials on a regional level. This position plays a crucial role in the development of new projects, ensuring that clinical trials are conducted efficiently, ethically, and within regulatory guidelines to bring important operations progression and results.

• Lead the operational execution of Phase 1–3 clinical trials at a regional level, with primary focus on obesity, overweight, metabolic disease, diabetes, and related indications
• Develop and maintain study timelines, operational plans, enrollment strategies, and key study milestones
• Manage study execution from protocol finalization and site start-up through enrollment, treatment, database lock, and study closeout
• Ensure that clinical trials are conducted according to regulatory requirements and organizational standards
• Partner with various internal and external stakeholders on protocol feasibility, operational considerations, and study implementation
• Monitor recruitment, retention, site performance, data quality, and study milestones and proactively address issues
• Serve as the primary operational contact and provide day-to-day oversight for assigned CROs and vendors
• Establish clear expectations for scope, deliverables, timelines, quality, and performance metrics.
• Review CRO performance against agreed-upon KPIs and study milestones
• Participate in vendor governance meetings and escalation activities
• Proactively identify operational risks and develop mitigation and contingency plans
• Manage vendor relationships with laboratories, imaging providers, central readers, IRT/IWRS providers, eCOA providers, and other study-specific vendors as applicable
• Support CRO selections, RFP, development and review of budgets, contracts, change orders, and invoices as part of vendor oversight
• Ensure external partners operate as an extension of the internal Clinical operations team

• Lead study start-up activities, including country/site feasibility, site selection, regulatory/ethics submissions, contracts, budgets, essential documents, and site activation
• Drive timely execution of study milestones from FPI through LPLV, database lock, and study close-out
• Develop strategies to optimize recruitment and retention, particularly for challenging obesity/metabolic populations
• Support investigator engagement and study communication activities
• Work with CROs and sites to resolve enrollment, protocol compliance, data quality, and operational issues

• Proactively identify operational risks, issues, and dependencies related to the clinical trial and develop appropriate mitigation and contingency plans
• Address any challenges in a timely and effective manner, ensuring the trial stays on track
• Ensure timely resolution of site and study issues

• Ensure clinical trials are conducted in accordance with ICH-GCP, applicable FDA and international regulations, the protocol, and company SOPs
• Oversee clinical monitoring activities and review monitoring metrics and findings
• Partner closely with Data Management to ensure timely data cleaning and resolution of data queries
• Monitor data quality and identify operational trends that could impact database lock
• Always maintain inspection readiness and support audits and regulatory inspections
• Ensure completeness and quality of the TMF and other essential study documentation
• Monitor and ensure the accuracy and integrity of clinical trial data

• Serve as a key clinical operations representative on cross-functional study teams
• Work with international teams across multiple time zones and countries to ensure successful global trial execution
• Collaborate closely with Clinical Development, Medical Affairs, Data Management, Biostatistics, Regulatory, Safety, and CMC/Drug Supply teams as appropriate
• Lead study team meetings and ensure clear documentation of decisions, action items, and timelines
• Provide regular updates to clinical and executive leadership regarding study progress, risks, issues, and mitigation strategies

• A bachelor’s degree (or higher) in life sciences, medicine, pharmacy, or a related field is typically required
• 7+ years of experience in clinical research/ clinical operations experience
  , with at least 4-5 years of clinical trial management experience
• Strong knowledge of ICH-Good Clinical Practice (GCP), FDA and other regulations, and clinical research requirements
• Experience with CTMS, EDC, eTMF
  , and other clinical trial technologies
• Demonstrated experience managing studies through multiple phases of the clinical development lifecycle
• Strong understanding of clinical trial processes, including study start-up, site management, recruitment, monitoring, data cleaning, and closeout
• Proven experience managing CROs, external vendors, and…