Associate Manager Start-Up France / Sponsor dedicated (Sourcing)

PAR Fortrea France SARL; Rueil-Malmaison; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A global contract research organization is seeking a candidate for overseeing clinical trial activities in France. Responsibilities include regulatory compliance, stakeholder collaboration, and project management. Applicants should possess a relevant university degree or equivalent experience, along with proficiency in French and English. This role offers competitive compensation and a permanent contract.

Prestations

Highly competitive compensation packages

Subsidized meals and transportation allowances

Bonus schemes / profit sharing

Regular salary adjustments

Employer contribution to pension scheme

Extensive insurance coverage

Excellent training opportunities

Flexible working hours

Permanent employment contract

Travel time as work time

Qualifications

• University degree in a life science or related field preferred.
• Proven experience in clinical trial operations and management.
• Basic understanding of regulatory requirements.

Responsabilités

• Oversee local operational clinical trial activities.
• Manage country deliverables and timelines.
• Collaborate with various internal and external stakeholders.

Connaissances

Fluent in French

Fluent in English

Knowledge of ICH Guidelines

Understanding of GCP

Regulatory requirements understanding

Formation

University / college degree in life science

Certification in allied health profession

4+ years of relevant clinical research experience

Description du poste

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.

Responsibilities

• Responsible for the execution and oversight of local operational clinical trial activities and the ownership, oversight, and impact on local regulatory and financial compliance for France.
• Responsible for the execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Develop local language materials including local language Informed Consents and translations.
• Work in partnership with IRB / IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
• Manage country deliverables, timelines and results for assigned protocols to meet country commitments.
• Contribute to the development of local SOPs.
• Collaborate 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.
• Collaborate closely with Regional Operations to align country timelines for assigned protocols.
• Provide support and oversight to local vendors as applicable.
• Handle financial duties including assistance with the ownership of country and site budgets.
• Oversee and track clinical research-related payments.
• Payment reconciliation at study close‑out.
• Responsible for clinical and ancillary supplies management, including import/export requirements, supplies destruction, local electronic/hard copy filing, archiving, retention requirements, and insurance process management.
• Enter and update country information in clinical, regulatory, safety and finance systems.

Benefits

• 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‑term and permanent disability and accident insurance.
• 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 a minimum of four or more years of relevant clinical research experience in pharmaceutical or CRO industries or 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.