Start-up Project Manager
- Employer
- Labcorp
- Location
- Rueil-Malmaison, France
- Salary
- Competitive
- Start date
- 28 Aug 2019
- Closing date
- 27 Sep 2019
View more
- Discipline
- Clinical Research, Study Start Up
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
This is a office based position in Paris area (92).
The Clinical Operation Manager will be responsible for execution and oversight of local operational clinical trial activities ina country for assigned protocols in compliance with ICH/GCP and country regulations.
STUDY START-UP
FINANCIAL:Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA) 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. Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
MANAGEMENT & QUALITY OVERSIGHT:Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to the development of local SOPs.
COLLABORATION:Works in close collaboration internally with GCTO country operations
LOCAL PROCESS OVERSIGHT/ Investigational Product management:Oversight and coordination of local processes.
Education/Qualifications:
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
- Fluent in French and in English, both written and verbal
- Relevant clinical research and start up experience in pharmaceutical or CRO industries
For more information on this career opportunity, please get directly in touch with Christelle Segabiot : christelle.segabiot@covance.com / +33141 05 73 38
Company
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.
- Website
- https://careers.labcorp.com/global/en
- Location
-
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom
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