Clinical Operation & Medical Project Specialist
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Job Description
KEY RESPONSIBILITIES
1. Project Management & Oversight
• Lead project planning, execution, monitoring, and reporting, ensuring adherence to timelines, budgets, and quality standards.
• Define and track key performance indicators (KPIs) for ongoing studies, including enrolment, data quality, and milestone achievement.
• Manage project risks, resolve operational challenges, and escalate critical issues to senior leadership when needed.
• Align data generation projects with global medical strategy and therapeutic area priorities to maximize scientific and commercial impact.
• Stay up to date with industry trends, methodologies, and regulatory requirements for real-world evidence, patient-reported outcomes, and post-marketing studies.
• Contribute to the development and implementation of new concepts, tools, and best practices in clinical data generation and project management.
• Build and maintain strong cross-functional collaboration and effective working relationships with investigators, site coordinators, and research organizations.
2. Data Quality, Integrity & Compliance
• Ensure data accuracy, completeness, and compliance with Good Clinical Practice (GCP), ICH guidelines, and regional health authority requirements (e.g., FDA, EMA, NMPA).
• Prepare and maintain documentation required for regulatory inspections, audits, and internal quality reviews.
3. Evidence Synthesis & Dissemination
• Contribute to the publication strategy by ensuring timely analysis, reporting, and dissemination of study results in peer-reviewed journals and at scientific congresses.
• Collaborate with Medical Affairs to integrate study findings into medical communication materials and medical education initiatives.
• Support the preparation of clinical study reports (CSRs), abstracts, manuscripts, and regulatory submission packages.
REQUIREMENTS:
Educational & Professional Background :
• Advanced degree in life sciences, pharmacy, medicine, public health, or related field
• Minimum 3 years of experience in clinical project management, clinical operations, or medical affairs within the pharmaceutical/biotech industry.
• Proven track record of leading Phase IIIb/IV trials, registries, or real-world evidence studies
• Strong understanding of clinical trial methodologies, GCP, ICH guidelines, and regulatory requirements..
• Excellent cross-functional project management skills, including budget management, timeline planning, and risk mitigation.
• Fluency in English (written and spoken)
Skills:
• Demonstrated ability to lead cross-functional teams and external collaborators with clarity, accountability, and strategic focus.
• Strong project management skills with proven ability to manage complex, multi-site studies on time and within budget.
• Ability to make decisions under pressure and manage competing priorities effectively.
• Experience in managing relationships with Contract Research Organizations (CROs) and external vendors.
• Capability to provide guidance on clinical research best practices.
Candidate Profile
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.