Description

Clinical Trial Manager - sponsor dedicated - Home based Paris Area - Average 2 to 5 days per month at Sponsor office based in Reims

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

Develop, coordinate, and implement clinical research studies at the organization's facilities, ensuring adherence to study protocols and timelinesCollaborate with the principal investigator to design study protocols and ensure scientific integrityLiaise between research subjects, client teams, investigators, and clinic operations teams to facilitate smooth communication and coordinationPlan logistics and resource usage for clinical trials, including scheduling, staffing, and equipment needsTrack study progress in alignment with project milestones, client deliverables, and budget, and provide regular updates to stakeholdersEnsure compliance with applicable regulations globally and by region, including Good Clinical Practice (GCP) guidelinesSupervise experienced support employees and/or entry-level individual contributors, planning, prioritizing, and directing their tasks to ensure efficient workflow and high-quality outputDeliver operational results that have a moderate impact on the immediate achievement of results for the team, contributing to the overall success of the organizationAdapt new procedures, techniques, and tools to improve clinical trial processes and outcomesUnderstand basic management approaches such as work scheduling, prioritizing, coaching, and process execution

Qualifications:

Broad job knowledge in an operational, administrative, and/or specialized fieldPractical knowledge in managing the execution of processes, projects, and tactics within a teamUnderstanding of the impact of work on related areas

Certifications:

Relevant certifications in clinical trial management or related fields

Necessary Skills:

Strong leadership and management skillsExcellent communication and collaboration abilitiesAbility to plan and prioritize tasks effectivelyProficiency in tracking and reporting study progressKnowledge of local and regional regulations for clinical trials

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

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

Supervision and/or preparation of study-related documents at the national level, based on reference materials provided by the global project leader. Ensure that all documents comply with local regulations and business procedures. Design and updating of dashboards required for monitoring the study at the national level. Liaison between stakeholders in the trial team, particularly with the preferred vendor for monitoring and administrative support. Lead trial follow-up meetings and prepare and distribute meeting minutes. Monitoring of recruitment progress. Implementation and tracking of site and patient engagement activities. Risk management and implementation of risk mitigation plans. Definition of financial resources (in partnership with contract experts) required for the study. Monitoring of the study budget and justification of any changes or adjustments. Ensuring database lock according to planned timelines. Maintaining strong relationships with study sites, including travel as needed. Oversight of site closures and administrative study close-out.