Project Manager Sponsor Dedicated France
- Experience Level
Here at Syneos Health, we are looking for a Project Manager to work sponsor dedicated. You will have the chance to work in exciting studies in oncology. The job location will be Client Based at La Defense.
As a Key Member of the Clinical Team, you will be responsible for all Clinical activities following study guidelines, SOPs and applicable Regulations.
Job Key Duties and Responsibilities:
- Reviews and approves monitoring reports and ensures that any detected issue (Protocol Deviation or non-Protocol Deviation) is reported in the Clinical Trial Management System and is adequately followed until closure.
- Supports sites and CRAs on any questions they may have during the course of the trial.
- Oversees activities and organizes regular teleconferences in order to follow-up on the activities they perform.
- Prepares, submits/oversees the submission of the documents requiring Ethics Committee approval (e.g. amended protocol/Informed Consent Form or other patients’ documents, Investigator Brochure).
- Participates in the development/review of trial operational documents, as well as global communications to sites/CRAs.
- Prepares and/or reviews training material for the CRAs on the trial/global calls with all CRAs and performs presentations.
- Performs Quality Controls (QCs) on the country/site files and works with the Administrative Project Coordinator(s) until resolution of any issue detected.
- Negotiates amendments to financial agreements with investigators/sites as per trial requirements.
- Reviews and approves invoices, supports finance with site fee reconciliation.
- Bachelor degree as a minimum. Scientific background (Nurse, Scientist, Pharmacist, M.D.)
- At least, 3 years of experience in monitoring or coordination of clinical projects.
- Good communication skills, both in written and oral.
- Excellent knowledge of ICH/GCP.
- Competitive remuneration package with excellent benefits
- Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
- Opportunity to work within a successful and rewarding environment
Are you interested?
If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.
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.