Associate Manager Start-Up France

il y a 4 semaines

Nantes, France Pharmiweb Temps plein
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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
  • In lieu of the above requirement, candidates with minimum of four or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
  • 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


We look forward to your application

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea 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.

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

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