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

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.

Skills and experience:
•    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.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  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 the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully 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.  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.

Summary

Roles within the Clinical Trial Management job family are responsible for overseeing the development, coordination, and implementation of Phase I-IV clinical research studies at the organization's facilities. Individuals in these roles collaborate closely with the principal investigator, serve as liaisons between research subjects, client teams, investigators, and clinic operations teams, and meticulously plan logistics and resource usage. These roles require tracking study progress in alignment with project milestones, client deliverables, and budget, while ensuring compliance with applicable regulations globally and by region. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.