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Protocol Manager - Sponsor dedicated - Based at Rueil Malmaison

Employer
Syneos Health
Location
Client-Based, FRA
Salary
Competitive
Start date
8 Apr 2021
Closing date
7 May 2021

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Job Details

Here at Syneos Health, we are looking for a Protocol 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 Rueil Malmaison with 2 days/week Home Based.

As a Key Member of the Clinical Team, you will be responsible for all Clinical activities following study guidelines, SOPs and applicable Regulations on non-interventional studies.

Job Key Duties and Responsibilities:
  • Project Management on Investigator Sponsored Research : Interventional studies and Non Interventional studies (NIR) or, post-ATU study and RTU
  • CRO Management: regulatory submission follow up with the CRO, conduct of the study follow up
  • Study documents review and validation: ICF, CRF, Global Site Management Plan and Monitoring Plan, eCRF completion guidelines
  • Communication Plan
  • Data review meeting participation
  • Budget reconciliation
  • Invoices validation
  • Kick off meeting organization
  • Study timelines management
  • CTMS supervision
  • Follow Up and review on Contract set up and protocol of Investigator Sponsor Research studies
  • Work closely with Internal medical department and external vendors
Qualifications:

  • Bachelor degree as a minimum. Scientific background (Nurse, Scientist, Pharmacist, M.D.)
  • At least, 5 years of experience in monitoring or coordination of clinical projects.
  • Excellent English level, both orally and in written.
  • Good communication skills, both in written and oral.
  • Excellent knowledge of ICH/GCP.
  • Benefits
  • Competitive remuneration package with excellent benefits and Sign On Bonus
  • 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.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

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About us:

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.

Disclaimer:

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.

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