Start-up Specialist France

Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers

If you are looking to take on responsibility and leverage your know-how in the start-up phase of clinical studies in France, this is the perfect opportunity. You will be working alongside our dedicated and supportive team of Regulatory and Site Readiness experts in a role that allows you to have a real impact on people’s health and lives.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

**Your tasks**:

- Prepare and performs Regulatory Submissions for France (EC, CA, CNOM, EU CTR Part II etc...) until authorization
- Prepare and negotiate Site Agreements (Site contract and budget) until execution and track progress of milestones / developments, intervening and escalating as appropriate
- Customize all country documents including Participant Information Sheet/ Informed Consent Form to ensure compliance with local requirements and protocol
- Serve as the primary contact for investigative sites, proactively managing site activation and providing guidance for your sites during the start-up phase of your assigned studies
- Ensure that all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH / GCP, SOPs, budget, quality and all applicable local laws and guidelines
- Collect, track and perform a quality review of all essential and investigator documents required for effective and compliant study site activation and maintenance
- Liaise with our regulatory department regarding document submission requirements and ensure documents required are collected and submitted on time. Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, taking ownership for compliance and audit readiness
- Escalate any issues with submissions and / or approvals for your assigned studies appropriately and in a timely fashion, both to internal departments and to external stakeholders such as Ethics Committees (ECs) and local regulatory authorities

**Education**:

- Degree in a relevant field such as pharmacology, life sciences, clinical trial management, (veterinarian) medicine, health care (management), nursing, chemistry, biology, etc.,
- In lieu of the above, an equivalent completed vocational education or equivalent professional experience

**Experience**:

- Solid expertise in clinical trials within a CRO or a pharmaceutical company with a specialization in clinical study start up / regulatory submissions
- Demonstrated understanding of research protocol requirements as well as the ability to communicate them / educate others about them
- Proven track record collaborating successfully with operational project teams as well as external investigative sites and local regulatory authorities (including ECs)
- Familiarity with investigator start-up documents and contract / budget negotiation processes with study sites
- Autonomous work style with excellent time and project management skills
- Business fluency in French and English - both spoken and written

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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