Clinical Data & Quality Manager

Resilience Care; Biarritz; Remote; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Remote work from France

Internal company events

Job summary

Resilience Care, a French company pioneering remote medical monitoring and clinical research, seeks a Compliance Lead for Good Clinical Practice across sponsored studies. You combine clinical quality, data integrity and system qualification while partnering with study teams and data workflows.

You ensure studies remain inspection-ready, data remains traceable, and regulatory requirements are embedded in everyday work.

Qualifications

• Five years of experience in Clinical Data Management and GCP compliance.
• Experience with regulatory inspections and audits.
• Experience with computerised system qualification.
• Familiar with EDC systems and ePRO/eCOA solutions.

Responsibilities

• Oversee study GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
• Maintain inspection readiness and support CRO oversight in line with ICH E6(R3).
• Qualify systems, assess test environments and review data extractions, audit trails and Data Management Plans.
• Work with Data and Clinical teams to build compliance into data workflows from the outset.
• Maintain clinical quality procedures, train teams and monitor regulatory developments.

Skills

GCP compliance

ICH E6(R3)

CAPAs & deviations

Audit readiness

EDC systems knowledge

Tools

Medidata Rave

Veeva

Oracle

Job description

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.

Your Role

In a few words

Within QARA, you oversee Good Clinical Practice compliance across Resilience’s sponsored studies and studies conducted with pharmaceutical partners. You combine clinical quality, data integrity and system qualification, working closely with the teams running studies and building data workflows.

Your impact

You help keep studies inspection-ready, data reliable and traceable, and compliance embedded in everyday work. Your role is to safeguard the framework and help teams apply it, rather than produce the data yourself.

Your day-to-day work

• Oversee study GCP compliance, manage deviations and corrective and preventive actions (CAPAs), and conduct quality and Trial Master File (TMF) reviews.
• Maintain inspection readiness and support CRO oversight in line with ICH E6(R3).
• Qualify systems, assess test environments and review data extractions, audit trails and Data Management Plans.
• Work with Data and Clinical teams to build compliance into data workflows from the outset.
• Maintain clinical quality procedures, train teams and monitor regulatory developments.

This is not a site-monitoring, data-engineering, study-project-management or routine clinical data-production role.

Your Team

Here, we don’t work in silos. You’ll join an agile structure where compliance is truly a team sport:

• Your Manager: Yasmine, the guardian of regulatory compliance for our medical devices. She will share her strategic vision of the healthcare sector with you and will be your go-to for the most sensitive decisions.
• Your core team: A trio of passionate experts. They’re your daily contacts for everything related to the quality management system, technical files, and audit preparation.
• The team’s little extra: A unique context where safety, clinical, and regulatory aspects come together to better serve patients, led by a team that combines rigor and kindness.

You join QARA and report directly to Yasmine. You work with Clinical Operations, Clinical Scientists, Data and Translational Research, as well as the DPO, CROs and pharmaceutical partners.

Candidate Profile

You are the right person if you know how to

• Apply ICH E6(R3), Annex 11 and 21 CFR Part 11 to clinical studies and systems.
• Manage deviations, CAPAs, audits and inspection preparation, beyond data cleaning alone.
• Qualify systems using CSV/CSQ approaches and apply ALCOA+ principles.
• Work with EDC systems and ePRO/eCOA solutions, translating their requirements into practical controls.
• Communicate and write fluently in English.

You are the right person if you have

• A rigorous approach that takes operational constraints into account.
• Practical judgement to turn requirements into workable processes.
• The ability to influence and train colleagues rather than impose rules.
• Confidence working across clinical and technical teams and with external partners.

You are the right person if you have already

• Gained at least five years of relevant experience in Clinical Data Management and GCP compliance within a pharmaceutical company or CRO.
• Handled clinical quality topics such as deviations, audits, inspections or procedures.
• Contributed to computerised system qualification.
• Worked with EDC systems, such as Medidata Rave, Veeva or Oracle, and ePRO/eCOA solutions.

It’s a plus if you

• Understand pipelines, ETL and databases, without needing to be a developer.
• Know CDISC standards for regulatory submissions.
• Want to move from data production to compliance oversight and help build quality practices.

Why join us?

• Contribute to reliable studies and data that support clinical research in oncology.
• Combine clinical quality, data integrity and collaboration with technical teams.
• Work remotely from France and meet colleagues at internal company events.

Recruitment Process

• Initial conversation with Elena.
• Interview with Yasmine, your future manager.
• Case study with Sarah and Yasmine from QARA.
• Team conversation with Nicoleta, Bertille and Alric.
• Strategic interview with Raph.

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.