Associate Manager Start Up France

il y a 1 semaine


RueilMalmaison, France Labcorp Temps plein

Join Labcorp Join the Pursuit

As a global life sciences leader, Labcorp provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients in their pursuit for answers. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. As a Labcorp employee, you can participate in transforming approaches to patient care.

In this role, you will be responsible for the execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance for France.

**Your responsibilities**:

- Responsible for the 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
- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
- Contributes to the development of local SOPs.
- Works in close collaboration internally with Clinical country operations, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Regional Operations to align country timelines for assigned protocols.
- Provides support and oversight to local vendors as applicable
- Financial duties including assistance with the ownership of country and site budgets
- Oversight and tracking of clinical research-related payments
- Payment reconciliation at study close-out
- Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Enters and updates country information in clinical, regulatory, safety and finance systems.

**What we offer**:

- Highly competitive compensation packages
- Subsidized meals and transportation allowances
- Bonus schemes / profit sharing
- Regular, merit-based salary adjustments
- Significant employer contribution to an attractive pension scheme
- Extensive insurance coverage, including medical, life, short as well as permanent disability and accidents
- Excellent training and career development opportunities as well as support with furthering your education
- Flexible working hours, capped overtime and compensatory time off in lieu
- Permanent employment contract
- Travel time = work time

**Education**:

- 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
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in French and in English, both written and verbal

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.


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