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

TN France; Rueil-Malmaison; Sur place; EUR 45 000 - 75 000; Plein temps

Résumé du poste

An established industry player is seeking an Associate Manager to lead clinical trial operations in France. This role involves overseeing submissions, managing timelines, and ensuring compliance with regulatory standards. You will collaborate with various departments and external partners to drive project success. The company offers competitive compensation, extensive training, and flexible working hours, fostering a collaborative environment for personal and professional growth. If you are a motivated problem-solver passionate about clinical research, this opportunity is perfect for you.

Prestations

Highly Competitive Compensation Packages

Subsidized Meals

Transportation Allowances

Merit-Based Salary Adjustments

Pension Scheme Contributions

Extensive Insurance Coverage

Training and Career Development

Flexible Working Hours

Compensatory Time Off

Qualifications

• University degree in life sciences or relevant certification.
• 4+ years of clinical research experience in CRO or pharmaceutical.

Responsabilités

• Oversee clinical trial submissions and approvals for assigned protocols.
• Collaborate with internal and external stakeholders for project success.

Connaissances

Clinical Trial Management

Regulatory Compliance

Financial Oversight

Project Management

Communication Skills

Formation

University/College Degree (Life Science Preferred)

Certification in Related Health Profession

Nursing Certification

Outils

Clinical Management Systems

Regulatory Submission Tools

Description du poste

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

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Client:

PAR Fortrea France SARL

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

fc3d05983a5a

Job Views:

3

Posted:

24.04.2025

Expiry Date:

08.06.2025

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Job Description:

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

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

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.