Job Overview:
Ready to expand your Start up / Regulatory career towards Project Management?
In Portugal, our sponsor dedicated team continues its expansion, and we have a new opportunity for a Local Start-up Project Manager
THE LOCAL START UP PROJECT MANAGER / PM JOB
You will work sponsor dedicated for a prestigious Top 5 global Pharmaceutical company.
This job is located in Paris , and we are prepared to offer a combination of home & office based work.
The job is perfect to gain a combined and rich experience within the CRO and Sponsor environments. It would suit existing:
CRO-based Senior Start-up Specialists or Local Start Up Project Managers looking for a closer partnership with a Sponsor, or Biopharmaceutical based Start-up Managers looking to have experience within a Global CRO.
Education/Qualifications:
You will have significant impact on how France deliver local Start-up, Regulatory and financial compliance commitments and objectives. As the main Local Operational responsible person in the country, your responsibilities will include, among others:
FINANCIAL
Assistance with the ownership of country and site budgets. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts. Oversight and tracking of clinical research-related payments Payment reconciliation at study close-out.
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations.
MANAGEMENT & QUALITY OVERSIGHT: Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Contributes to the development of local SOPs.
Experience:
WHAT MAKES THESE JOBS SPECIAL
If you come from a CRO environment, you´ll value being exposed to a rich interaction with internal client partners such as Finance, Med Affairs, Quality, Legal and Regional Operations, Head Quarter functional areas?
This is a pure customer-facing role, allowing you to build high-level business relationships, representing the sponsor to IRB/IECs and Regulatory Authorities, vendors and external partners to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones