Single Sponsor Clinical Trial Manager ; Late Phase French speaking - Hybrid

Single Sponsor Clinical Trial Manager I (Late Phase) – French speaking – Hybrid in London Job Responsibilities

• Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions.
• Participate in and manage project meetings and conference calls with CROs, vendors, and multi‑functional teams.
• Anticipate obstacles and proactively develop solutions to achieve project goals.
• Develop a general understanding of functional issues and routine project goals from an organizational perspective.
• Participate in abstract presentations, oral presentations, and manuscript development activities.
• Interact and cooperate with individuals in other functional areas to address routine study issues.
• Develop tools and processes that increase measured efficiencies of the project.
• Assist in training for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs).
• Assist in selecting Contract Research Organizations (CROs) or vendors.
• Coordinate CROs and vendors.
• Responsible for updating study timelines.
• Participate in departmental, or interdepartmental, strategic initiatives under general supervision.
• Assist in review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• Conduct site evaluation, initiation, co‑monitoring, and close‑out visits, in addition to routine monitoring visits.
• Assure site compliance with the protocol and regulatory requirements for assigned studies.
• Draft and coordinate review of protocols, informed consents, case report forms, and study plans as needed.

• Excellent verbal, written, interpersonal and presentation skills.
• Knowledge of FDA and/or EMA regulations (or relevant local regulations), ICH guidelines, and GCP governing the conduct of clinical studies.
• Working knowledge of Microsoft Word, PowerPoint, Project and Excel.
• At least 4+ years of clinical experience and a BS/BA in a relevant scientific discipline.

The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in this Job Description. The Company will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company will comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.