Clinical Operations Lead France Sponsor Dedicated
- Experience Level
Here at Syneos Health, we are looking for a Clinical Operations Lead to work sponsor dedicated. You will have the chance to work in exciting international 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:
- Involved in site selection, follow startup activities and submission timelines closely.
- Perform accompanied visits during sites selection/ initiation and monitoring.
- Ensures quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. May include the development of the Clinical Management Plan (CMP)/Site Management Plan (SMP).
- Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.
- Ensures alignment of clinical activities to budget, including identification of out of scope activities.
- May participates in business development proposals, defense meetings and proposal development.
- As required, provides development and delivery of initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Plans and leads regular clinical study team calls to provide status updates, ongoing training and accountability to deliverables.
- Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
- Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan. Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
- 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.
- 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.