Paris, Ile-de-France, France · Remote OK
Join Our Team and Drive Clinical Research Success! At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist I, you will play a pivotal role in coordin…
Skills: Clinical research, Regulatory submissions, Site activation, ICH/GCP guidelines, Regulatory compliance
Paris, Ile-de-France, France · Hybrid
Title: Stagiaire Relations Investisseur et Fusions Acquisitions H/F - 6 mois / Investor Relations and M&A Intern - 6 months Company: Ipsen Pharma (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company w…
Skills: Financial analysis, Financial modeling, Investor relations, Mergers and acquisitions, Market analysis
Paris, Ile-de-France, France · On-site
$72k–$81k/yr
Founded in 2020 and based in the heart of Paris, C12’s mission is to be at the center of one of the biggest technological breakthroughs of the century and change the course of history by building a universal quantum comp…
Skills: Operations management, Reliability engineering, Preventive maintenance, Facility management, Team leadership
Paris, Ile-de-France, France · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate I – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharma…
Skills: Clinical monitoring, Site management, ICH-GCP guidelines, Regulatory compliance, Risk-based monitoring
Paris, Ile-de-France, France · On-site
Title: Global Asset Lead, Iqirvo Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Ra…
Skills: Oncology, Strategic leadership, Asset management, Cross-functional team leadership, Clinical development
Paris, Ile-de-France, France · Remote Solely
$7k/mo
JOB DETAILS Type of contract : Consultant Contract Level : Level 3 - Senior Hiring Unit : Communication and Information Sector (CI) Duty Station : Paris Work location : Remote Duration of contract : 11 months Hiring open…
Skills: Open Data, Open Science, Open Educational Resources, Diamond Open Access, Project Management
Paris, Ile-de-France, France · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as an Assistant Clinical Research Associate – Make an Impact at the Forefront of Innovation We have successfully supported the top …
Skills: Clinical research, Site management, Regulatory compliance, ICH GCP, Data reconciliation
Paris, Ile-de-France, France · Hybrid
Job Description An amazing opportunity has arisen for a Clinical Research Manager (CRM) Lead. We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innova…
Skills: Clinical Research Management, Clinical Sciences, Clinical Study Design, Decision Making, Early Clinical Development
Paris, Ile-de-France, France · On-site
$130k–$133k/yr
Minimum qualifications: PhD in Computer Science, a related field, or equivalent practical experience. 4 years of experience working with compilers and performance optimization. 4 years of experience programming in C++. 4…
Skills: C++, Compilers, Performance optimization, Machine learning, MLIR
Paris, Ile-de-France, France · Remote Solely
About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go ha…
Skills: Trial Master File, eTMF, Clinical Operations, ICH-GCP, Clinical Research Administration
Paris, Ile-de-France, France · On-site
APERÇU Numéro de poste : IOC 001 Classe : ADG Secteur de tutelle : Commission océanographique intergouvernementale (IOC) Lieu d'affectation : Paris Domaine : Coordination des programmes Type de contrat : Engagement de du…
Skills: Strategic Leadership, International Cooperation, Financial Management, Fundraising, High-level Negotiation
Paris, Ile-de-France, France · On-site
OVERVIEW Position Number: IOC 001 Grade: ADG Parent Sector: Intergovernmental Oceanographic Commission (IOC) Duty Station: Paris Job Family: Programme Coordination Contract Type: Fixed Term Duration of contract: 2 years,…
Skills: Senior Executive Management, International Cooperation, Strategic Thinking, Fundraising, Financial Management
Paris, Ile-de-France, France · Hybrid
CRA I SSU ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboratio…
Skills: Clinical Trial Monitoring, Site Qualification, Protocol Compliance, Data Integrity, Patient Safety
Paris, Ile-de-France, France · Remote Solely
$40/hr–$40/hr
Location: Remote Type: Contract / Part-time Commitment: 20 hours per week Compensation: Up to 40 USD / hr Project duration: 2 months, with potential extension About the role We create high-quality STEM training data for …
Skills: Biology, Python, Bioinformatics, Computational Biology, Genetics
Paris, Ile-de-France, France · Hybrid
Title: Global Patient Safety Senior Scientist Rare Diseases Company: Ipsen Pharma (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic are…
Skills: Pharmacovigilance, Safety surveillance, Risk management, Signal detection, Clinical development
Paris, Ile-de-France, France · On-site
About the company The transition to a sustainable future requires discovering new mineral resources to power clean technologies and renewable energy solutions. From lithium for electric vehicle batteries, to copper for w…
Skills: Mineral exploration, Geology, Field mapping, Core logging, Sampling
Paris, Ile-de-France, France · Hybrid
Intitulé du poste: stage 6 mois – ingénierie logicielle native IA Lieu : Paris 17e arrtA partir de : janvier 2027 À propos du poste En tant que stagiaire ingénierie logiciel natif IA au sein de notre équipe AI Engineerin…
Skills: Python, Typescript, Claude Code, Cursor, Scripting
Paris, Ile-de-France, France · Hybrid
Title: Global Patient Safety Asset Lead, Rare Diseases Company: Ipsen Pharma (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: O…
Skills: Pharmacovigilance, Risk Management, Clinical Development, Benefit-Risk Assessment, Regulatory Submissions
Paris, Ile-de-France, France · On-site
Description de l'entreprise L’Organisation de coopération et de développement économiques (OCDE) est une organisation internationale regroupant 38 pays Membres, qui œuvre pour la mise en place de politiques meilleures po…
Skills: Electrical engineering, Power systems modeling, Grid modernization, Electricity market analysis, Energy policy
Paris, Ile-de-France, France · Hybrid
Doctolib recherche un(e) stagiaire en contenu médical pour rejoindre la partie affaires médicales de notre équipe Medical Excellence et contribuer à la réalisation d'initiatives médicales ayant un impact direct sur la sa…
Skills: Medical Content Creation, Medical Validation, Project Management, Analytical Skills, Communication
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The role involves serving as the primary contact for investigative sites, managing essential regulatory documents, and ensuring compliance with ICH/GCP guidelines. You will also coordinate site start-up activities, track submission timelines, and assist in the negotiation of site contracts and budgets.
Candidates must hold a university or college degree in life sciences or a related allied health profession and possess at least 18 months of experience in clinical research or regulatory submissions. Strong knowledge of regulatory requirements and proficiency in document management systems are essential for success in this position.
At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist I, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster.
In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications.
Key Responsibilities:
In this role, you will:
Serve as the primary contact for investigative sites during start-up and maintenance activities.
Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
Track submission timelines and proactively address potential delays.
Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
Ensure all documentation is audit-ready and systems are consistently updated.
Assist in the negotiation of site contracts and budgets, if applicable.
Provide mentorship and training to new hires and less-experienced colleagues.
Required Qualifications:
To succeed in this role, you should have:
University/College degree (life sciences preferred) or certification in a related allied health profession.
Minimum 18 months of experience in clinical research, regulatory submissions, or site activation.
Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
Experience interacting with regulatory authorities and site start-up teams.
Excellent organizational, problem-solving, and communication skills.
Proficiency in Microsoft Office and document management systems.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
What We Offer:
Competitive salary and performance-based incentives.
Flexible work arrangements (remote/hybrid options).
Professional growth opportunities in a collaborative and innovative environment.
The opportunity to work on cutting-edge clinical research projects.
Ready to Make an Impact?
Join us in shaping the future of clinical research. Apply today!
Applications are reviewed on a rolling basis—don’t miss this opportunity!
Learn more about our EEO & Accommodations request here.
Bringing life-changing benefits to patients faster
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators. Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas. Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes. Together, exceptional is possible. Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
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