Sr. Clinical Project Manager

We are seeking an experienced, highly organized, and collaborative Senior Clinical Trial Manageras 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.Clinical Trial Management and Execution: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 indicationsDevelop and maintain study timelines, operational plans, enrollment strategies, and key study milestonesManage study execution from protocol finalization and site start-up through enrollment, treatment, database lock, and study closeoutEnsure that clinical trials are conducted according to regulatory requirements and organizational standardsPartner with various internal and external stakeholders on protocol feasibility, operational considerations, and study implementationMonitor recruitment, retention, site performance, data quality, and study milestones and proactively address issuesCRO & Vendor Management:Serve as the primary operational contact and provide day-to-day oversight for assigned CROs and vendorsEstablish clear expectations for scope, deliverables, timelines, quality, and performance metrics.Review CRO performance against agreed-upon KPIs and study milestonesParticipate in vendor governance meetings and escalation activitiesProactively identify operational risks and develop mitigation and contingency plansManage vendor relationships with laboratories, imaging providers, central readers, IRT/IWRS providers, eCOA providers, and other study-specific vendors as applicableSupport CRO selections, RFP, development and review of budgets, contracts, change orders, and invoices as part of vendor oversightEnsure external partners operate as an extension of the internal Clinical operations teamStudy Start-up, Site Management and Patient Recruitment:Lead study start-up activities, including country/site feasibility, site selection, regulatory/ethics submissions, contracts, budgets, essential documents, and site activationDrive timely execution of study milestones from FPI through LPLV, database lock, and study close-outDevelop strategies to optimize recruitment and retention, particularly for challenging obesity/metabolic populationsSupport investigator engagement and study communication activitiesWork with CROs and sites to resolve enrollment, protocol compliance, data quality, and operational issuesRisk and Issue Management:Proactively identify operational risks, issues, and dependencies related to the clinical trial and develop appropriate mitigation and contingency plansAddress any challenges in a timely and effective manner, ensuring the trial stays on trackEnsure timely resolution of site and study issuesData Quality and Compliance:Ensure clinical trials are conducted in accordance with ICH-GCP, applicable FDA and international regulations, the protocol, and company SOPsOversee clinical monitoring activities and review monitoring metrics and findingsPartner closely with Data Management to ensure timely data cleaning and resolution of data queriesMonitor data quality and identify operational trends that could impact database lockAlways maintain inspection readiness and support audits and regulatory inspectionsEnsure completeness and quality of the TMF and other essential study documentationMonitor and ensure the accuracy and integrity of clinical trial dataCross-Functional Collaboration:Serve as a key clinical operations representative on cross-functional study teamsWork with international teams across multiple time zones and countries to ensure successful global trial executionCollaborate closely with Clinical Development, Medical Affairs, Data Management, Biostatistics, Regulatory, Safety, and CMC/Drug Supply teams as appropriateLead study team meetings and ensure clear documentation of decisions, action items, and timelinesProvide regular updates to clinical and executive leadership regarding study progress, risks, issues, and mitigation strategies

Qualifications

A bachelor’s degree (or higher) in life sciences, medicine, pharmacy, or a related field is typically required7+ years of experience in clinical research/ clinical operations experience, with at least 4-5 years of clinical trial management experienceStrong knowledge of ICH-Good Clinical Practice (GCP), FDA and other regulations, and clinical research requirementsExperience with CTMS, EDC, eTMF, and other clinical trial technologiesDemonstrated experience managing studies through multiple phases of the clinical development lifecycleStrong understanding of clinical trial processes, including study start-up, site management, recruitment, monitoring, data cleaning, and closeoutProven experience managing CROs, external vendors, and cross-functional teamsAbility to manage multiple priorities and work effectively in a matrix environmentStrong analytical skills to identify problems, assess risks, and develop effective solutions to ensure the trial’s successStrong program management, organizational, communication and multitasking skills to manage complex projects and ensure timelines are metAbility to lead teams, collaborate with cross-functional stakeholders, and communicate effectively with both internal and external partiesFlexibility and adaptability to handle regional challenges and differences