Clinical Operations Project Manager

About Servier

With commercial stage products and a promising pipeline, we are a US-based affiliate of Servier Group, a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non-profit foundation, we have multiple medicines approved in oncology & other disease states globally. Additionally, we have accelerated our investments with an ambition to further establish ourselves as innovators in the Oncology space. Over half of our research and development efforts are specifically focused on delivering significant advances in targeted therapies to treat patient communities with unmet needs. At Servier, you will join a highly skilled team dedicated to bringing the promise of tomorrow to the patients we serve.

Role Summary

The Clinical Operations Project Manager will be responsible for overseeing the execution of clinical trials in North America, ensuring compliance with applicable regulations, Good Clinical Practice, company’s Standard Operating Procedures and study protocol. In this role you will work closely with cross-functional teams to ensure successful completion of studies within timelines and budget, with a focus on quality to support operational excellence and world class clinical study management.

Primary 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

Education and Required Skills

• Bachelor’s degree or equivalent experience required in Scientific/health care related field, with a minimum of 5 years of overall relevant clinical research experience, including either:
  • 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
• Hematology/Oncology experience preferred
• 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.

Travel and Location

• Travel up to 25% of the position time
• Remote position, East Coast is preferred.

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range

The salary range for this role is $132,000 - $152,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.