Local Project Manager in Oncology - Sponsor dedicated - Based in Paris or Home Based France

Description

Here at Syneos Health, we are looking for a Local Project Manager to work sponsor dedicated. You will have the chance to work in exciting studies in Oncology or Rare Disease.

The job location will be Client Based at Paris / 50% Home Based or Home Based in France.

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

Responsible For :

• Timely and accurate responses to queries from the study team.
• Proposing potential investigator sites in collaboration with other country functions.
• Working with Medical Affairs to coordinate site feasibility.
• Oversight of EC / CA submissions and facilitate resolution of queries.
• Reviewing and approving site selection visit reports.
• Coordination of study specific training of CRAs for assigned trials.
• Oversight of dedicated or FSP CRAs on assigned studies.
• Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies and communicate monitoring deficiencies.
• Inspection readiness activities coordination at local level for assigned studies.
• Relationship management with sites.
• Providing feedback to Internal and External Stakeholders as appropriate according to the relevant plans.
• Developing and maintaining project management tracking tools.
• Driving quality efforts to proactively identify and manage risks to study quality.
• Supporting CRAs onboarding, particularly for study specific trainings.

Qualifications

Qualifications :

• Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process.
• Solid knowledge of clinical development processes.
• Ability to lead, troubleshoot and influence for quality and delivery.
• A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected.
• Proven experience in effectively communicating with site staff including and including KOLs and thought leaders.
• Comprehensive and current regulatory knowledge, including GCP.
• Experience conducting GCP or other training is a plus.
• Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods).
• Good organizational skills and ability to deal with competing priorities
• Effective communication skills (written, verbal and presentation)
• Creative thinker, curious and unafraid to ask questions
• Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
• Proficient with MS Office Suite (Excel, Word and PowerPoint).

Benefits

• 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.

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.