Clinical Operations Project Manager

Servier is a US-based affiliate of Servier Group, a global organization focused on oncology and other disease states. The Clinical Operations Project Manager will oversee the execution of clinical trials in North America, ensuring compliance with regulations and effective collaboration with cross-functional teams to deliver studies on time and within budget.

Responsibilities:

• Accountable for end-to-end clinical trial execution at the local level, from planning, feasibility, start up, conduct, to close-out of clinical trials, ensuring delivery against timelines, protocol and amendments, and regulatory guidelines
• Contribute to the development of monitoring strategies and plans, ensuring effective execution through oversight of in-house and CRO monitoring activities, including the implementation of risk-based monitoring approaches
• Proactively identify, assess, and mitigate risks related to the trial conduct, follow the study risk register document
• Responsible for managing local site budget preparation and vendor contracts for assigned studies, including the approval of change orders to ensure financial alignment
• Prepare and conduct local investigator meetings
• Develop and drive patient recruitment and retention strategies in collaboration with Study Team, monitoring enrollment against the projections and escalate risks to the Study Team
• Coordinate implementation of protocol amendments across all sites, ensuring timely IRB submissions, site training, and update of related documents
• Oversee CRA’s and ensure study-specific training of the local team: CRAs, study assistants/associates, and other R&D team members
• Ensure constant state of inspection readiness by maintaining accuracy and completeness of sponsor study files at the national and site levels, acting as the Subject Matter Expert (SME) during regulatory inspections
• In cooperation with the local or regional Pharmacovigilance manager, follow up on pharmacovigilance aspects including required reporting
• Supervise local IMP management including local storage and distribution to sites
• Accountable for accuracy and timeliness of information in all clinical trial databases and tracking systems, collaborating with global data management and medical review teams to support data analysis
• Track the quality of the study (protocol deviations, CAPA plans escalated by local teams, participation in Data Review and Surveillance meetings) and report important issues to the global Study Team
• Provide regular study status updates and KPI/metrics reporting to management, maintain stakeholder alignment through escalation pathways and governance meetings
• Partner with Regulatory Affairs and other stakeholders to ensure timely reporting, data analysis, country-level regulatory submissions, and alignment across study activities

Requirements:

• Bachelor's degree or equivalent experience required in Scientific/health care related field
• Minimum of 5 years of overall relevant clinical research experience
• Experience as a Clinical Project Manager or similar position within a pharmaceutical company or CRO, or at least 3 years of experience as a Senior CRA
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality, and project delivery
• In-depth knowledge of current FDA and local IRBs regulatory requirements, ICH-GCP and guidelines governing clinical research
• Ability to oversee, manage and communicate effectively with clinical sites and research vendors
• Strong attention to detail and the ability to establish priorities schedule and meet deadlines
• Ability to work independently and take initiatives
• Respectfully challenges current practices, decisions, or ideas to promote quality and continuous improvement
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams and external collaborators
• Hematology/Oncology experience preferred