We are seeking an experienced, highly organized, and collaborative Senior Clinical Trial Manager 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.
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 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
Study 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 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
Risk and Issue Management:
- 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
Data Quality and Compliance:
- 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
Cross-Functional Collaboration:
- 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
Qualifications:
- 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 cross-functional teams
- Ability to manage multiple priorities and work effectively in a matrix environment
- Strong analytical skills to identify problems, assess risks , and develop effective solutions to ensure the trial’s success
- Strong program management, organizational, communication and multitasking skills to manage complex projects and ensure timelines are met
- Ability to lead teams, collaborate with cross-functional stakeholders, and communicate effectively with both internal and external parties
- Flexibility and adaptability to handle regional challenges and differences
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