Clinical Trial Manager - Contract 12 months

Resilience Care; Rennes; Remoto; EUR 55.000 - 85.000; Tempo integral

Benefícios oferecidos por esta vaga

Fully remote within France

Regular travel

Resumo da vaga

Resilience Care, a forward‑looking French company specializing in remote medical monitoring, seeks a Clinical Operations Coordinator to oversee multi-site studies across therapeutic areas. You will report to the Clinical Operations Lead and blend hands-on site oversight with regulatory coordination.

You will ensure data quality, maintain regulatory documentation, and support budget tracking while collaborating with Clinical Scientists, Biostatistics and Product teams.

Qualificações

• Degree in life sciences, pharmacy, clinical research or biomedical engineering.
• At least two years of experience in clinical research (e.g., CRA, site manager, or junior PM).
• Experience in operational follow-up of clinical sites or studies.
• Ability to work in French and English with professional fluency.

Responsabilidades

• Coordinate day-to-day study operations and logistics, and support site selection, initiation, monitoring and close-out visits.
• Track site progress, study indicators and data quality; share issues during governance meetings.
• Follow up on site agreements, amendments and budget annexes; contribute to site budget tracking and payment follow-up with Legal and Finance.
• Maintain regulatory documentation and the eTMF; support audit readiness and ensure compliance with GCP, ICH guidelines, the French Jardé Law and GDPR.
• Work with Clinical Scientists, Biostatistics and Product teams to improve clinical operations trackers and SOPs.

Conhecimentos

Study coordination

GCP / ICH / GDPR

Documentation management

Regulatory submission

Cross-functional communication

Formação

Degree in life sciences, pharmacy, clinical research or biomedical engineering

Descrição da vaga

The Company

Resilience Care, a leading player in remote medical monitoring and a partner in clinical research, is a French company founded in 2021 with a single mission: to provide better care.

The Company

Resilience Care, a leading player in remote medical monitoring and a partner in clinical research, is a French company founded in 2021 with a single mission: to provide better care. Our company offers remote monitoring solutions in oncology, gastroenterology, and psychiatry, based on the collection of ePROs combined with AI technologies. These solutions rely on a monitoring platform for healthcare professionals—enabling the early detection of side effects for continuous and proactive care—and a mobile app for patients, empowering them to measure and manage their symptoms using tailored resources. Our solutions optimize patient care, continuously enrich our understanding of patients throughout their healthcare journey, and accelerate clinical research through the collection, structuring, and in-depth analysis of real-world data. Today, our solutions are deployed in routine care for 35,000 patients across more than 200 healthcare facilities, as well as within the framework of around twenty academic and industrial clinical trials. Through this, we put data at the service of healthcare and therapeutic innovation, driven by the ambition to enable every patient to benefit from personalized medicine.

In a few words

You will coordinate the operations of Resilience-sponsored and investigator-initiated studies across several therapeutic areas. Reporting to a Clinical Operations Lead (COPL), you will combine hands-on site oversight with regulatory and contractual coordination and improvements to clinical operations processes.

Your impact

Help sites deliver studies effectively: follow protocols, maintain up-to-date documentation and ensure data quality. You will connect the teams involved so that operational, regulatory and contractual activities progress together.

Your day to day

• Coordinate day-to-day study operations and logistics, and support the planning and follow-up of site selection, initiation, monitoring and close-out visits.
• Track site progress, study indicators and data quality, and share issues requiring attention during study meetings and governance committees.
• Follow up on site agreements, amendments and budget annexes, and contribute to site budget tracking and payment follow-up with Legal and Finance.
• Maintain regulatory documentation and the eTMF, support audit readiness and ensure compliance with GCP, applicable ICH guidelines, the French Jardé Law and GDPR.
• Work with Clinical Scientists, Biostatistics and Product teams, and improve clinical operations trackers, standard operating procedures and templates.

Your team

• Your future colleagues: you will work with Clinical Scientists, Biostatistics and Product teams, as well as Legal and Finance.
• Your manager: Anne-Julie, the Hiring Manager for this role. She has over 10 years of experience, including in the pharmaceutical industry, and has been Clinical Operations Lead at Resilience for the past year and a half.
• The little about your team: We work together to find practical solutions—and make time to celebrate our wins along the way.

Candidate Profile

You are the right person if you know how to

• Organize clinical study activities and track priorities, deadlines and actions across stakeholders.
• Apply GCP and the relevant requirements of ICH guidelines, the French Jardé Law and GDPR.
• Maintain structured study documentation and use study indicators to monitor progress.
• Contribute to regulatory submission follow-up, site contracting and budget tracking.
• Work in French and English with professional fluency, both written and spoken.

You are the right person if you have

• A structured approach to work and close attention to detail.
• The ability to work independently and prioritize effectively.
• Clear communication skills across different functions.
• Curiosity and a resourceful, practical approach to solving problems.
• A collaborative mindset and the ability to adapt when priorities change.

You are the right person if you have already

• Earned a degree in life sciences, pharmacy, clinical research or biomedical engineering.
• Gained at least two years of experience in clinical research, for example as a CRA, site manager or junior project manager.
• Contributed to the operational follow-up of clinical sites or studies.

Why join us?

• Contribute to studies that combine clinical research, digital tools and patient-centered monitoring.
• Build on your operational experience while developing regulatory and contractual coordination skills.
• Work across several therapeutic areas with colleagues from complementary disciplines.
• Improve the methods and tools used in day-to-day clinical operations.
• Work fully remotely within France, with regular travel related to the role.

Recruitment Process

• One-on-one screening with Elena — 20 minutes: discuss your motivation and alignment with the role and Resilience’s culture.
• Interview with Anne-Julie, Hiring Manager - 30 minutes: explore your background and the skills relevant to the role.
• Case study: a practical exercise related to the role’s responsibilities.
• Team interview with the Medical team - 30minutes /ITW: meet team members and discuss day-to-day collaboration.

GDPR

Your personal data will be processed for the purposes of recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. They will be available only for people involved in the process and erased after 2 years of inactivity. Under GDPR and as Resilience attach great importance to privacy, please note that you have the right to request access to your personal data, to request that your personal data be rectified or erased. The Data Protection Officer can be contacted at [e-mail]. For more information, please check our privacy policy.