Single Sponsor Clinical Trial Manager I (Late Phase) French speaking - Hybrid in London

Requirements

• Excellent verbal, written, interpersonal and presentation skills are required
• Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
• Working knowledge and experience with Word, PowerPoint, Project and Excel
• Experience and Skills:
• At least 4+ years of clinical experience and a BS/BA in a relevant scientific discipline.
• Get to know Syneos Health
• Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
• No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
• http://www.syneoshealth.com
• Additional Information

Benefits

Additional Information

Single Sponsor Clinical Trial Manager I (Late Phase) French speaking - Hybrid in London Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 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. - Able to 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. - Coordinates CROs and vendors. - Responsible in updating of 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 closeout visits, in addition to the routine monitoring visits. - Assure the 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.

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