Chargée d'Etudes Cliniques Sénior in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Chargée d’Etudes Cliniques Sénior (Clinical Trials Manager) in the United States.

This role plays a key part in the operational delivery of complex oncology clinical trials, ensuring end-to-end execution across Phase II and III studies. You will be responsible for coordinating cross-functional activities, overseeing external partners, and ensuring alignment between internal teams and CROs or vendors. The position requires strong project management and clinical trial expertise to maintain timelines, manage risks, and support high-quality study delivery. You will contribute directly to protocol development, study planning, and operational oversight while ensuring compliance with regulatory standards and GCP guidelines. Working in a highly collaborative environment, you will act as a central point of coordination across global stakeholders. This is a high-impact role within oncology development, where your work directly supports the advancement of innovative therapies.

• Coordinate and oversee all operational aspects of clinical trials from start-up through close-out, ensuring smooth execution of Phase II and III oncology studies.
• Support clinical program managers in overall study planning, execution, and issue resolution.
• Contribute to the development and review of key study documents, including protocols, case report forms, informed consents, study plans, and final reports.
• Maintain study timelines and ensure accurate documentation, communication, and tracking of study activities.
• Assist in developing study budgets and support financial tracking related to clinical operations.
• Participate in CRO and vendor selection, including RFP development and evaluation processes.
• Oversee CROs, vendors, and functional service providers to ensure compliance with protocols, SOPs, and regulatory requirements.
• Monitor study sites and ensure proper execution of site initiation, evaluation, monitoring, and close-out activities.
• Review regulatory documents and resolve data discrepancies in collaboration with cross-functional teams.
• Support preparation of interim and final clinical study reports, including data listings and appendices.
• Contribute to process improvements, tool development, and operational efficiencies across clinical study management.
• Provide training and guidance to CROs, investigators, and study coordinators as needed.
• Ensure adherence to FDA, EMA, ICH, and GCP regulations across assigned studies.

• Bachelor’s degree with 5+ years of experience in a relevant scientific discipline, or Master’s degree with 3+ years of experience.
• Strong experience in clinical trial management, preferably within oncology.
• Background in CRO, pharmaceutical, or biotechnology environments is required.
• Solid understanding of clinical operations, study design, and trial execution processes.
• Knowledge of regulatory frameworks including FDA, EMA, ICH guidelines, and GCP standards.
• Proven ability to manage CROs, vendors, and cross-functional stakeholders in complex clinical studies.
• Strong project management, organizational, and problem-solving skills.
• Ability to interpret and communicate protocol requirements clearly to internal and external teams.
• Excellent communication, teamwork, and decision-making abilities.
• Ability to manage multiple priorities in a fast-paced, global clinical research environment.
• Willingness to travel as required for study oversight activities.

• Competitive compensation package including base salary ranging from $133,195 to $172,370 depending on experience and location.
• Eligibility for annual discretionary bonus and long-term incentive programs (role-dependent).
• Comprehensive health benefits including medical, dental, vision, and life insurance.
• Paid time off and additional well-being programs.
• Opportunity to work on high-impact oncology clinical trials with global reach.
• Exposure to end-to-end clinical study management in a leading biopharmaceutical environment.
• Strong emphasis on professional development and cross-functional collaboration.
• Inclusive and diverse workplace culture supporting individual growth and contribution.