Role Description
You will lead all of Resilience’s clinical operations: Resilience-sponsored randomised controlled trials (RCTs), investigator-initiated studies (ISRs), real-world evidence (RWE) projects and studies conducted for industry partners. You will report directly to the Chief Medical Officer, manage a team of five to six people, including CTMs and Senior CTMs, and step in operationally on projects when backup is needed.
Your impact
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Ensure that every study is delivered on time, within budget and to the expected quality standards.
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Keep the team’s workload manageable.
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Provide the medical leadership team with a reliable overview of the study portfolio, including timelines, budgets and the risk register.
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Prepare clinical operations to support a growing number of industry partners.
Your day-to-day responsibilities
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Lead the study portfolio: manage budgets, timelines, risk registers, GCP compliance, milestones and performance indicators; run the weekly review of all projects and their reporting.
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Allocate projects and manage the team’s workload: assign tasks, organise backup, prioritise and anticipate recruitment needs.
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Manage and develop the team—Senior CTMs, CTMs and Clinical Research Associates (CRAs)—through goal-setting, reviews and coaching.
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Ensure quality and compliance: maintain standard operating procedures (SOPs), templates and tools; prepare for audits and inspections; ensure compliance with GCP, ICH guidelines, the French Jardé law and GDPR.
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Act as the escalation point for sites, investigators and partners on delays, budget overruns and quality issues.
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Build the operational model for our clinical research offering for industry partners, including study costing, processes, tools and staffing, in collaboration with the Commercial, Legal and Finance teams.
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Work cross-functionally across Resilience, including with Clinical Development, Biostatistics, Data Management, Finance, Regulatory, Compliance, Market Access and Product.
Qualifications
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Manage several studies in parallel, including their budgets, timelines, resources and risks.
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Lead a clinical operations team, balance workloads and develop each team member’s autonomy.
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Estimate study costs, build budgets and monitor spending.
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Build and maintain a quality system—including SOPs, templates and audit preparation—that complies with GCP, ICH guidelines, the French Jardé law and GDPR.
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Manage relationships with sites, investigators and industry partners, including in escalation situations.
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Work in English at a professional level, both written and spoken.
Requirements
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A degree in life sciences, pharmacy, clinical research or biomedical engineering—MSc, MD, PharmD or PhD.
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At least eight years of experience in clinical research, including three years managing a team or a study portfolio.
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Led studies for sponsors or industry partners in a CRO, pharmaceutical, biotech or medtech environment.
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Ideally, experience with real-world studies or medical devices. Knowledge of ISO 14155 is a plus.
Benefits
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Lead clinical operations at a growing medtech company.
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Shape the team’s organisation, processes and tools.
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Help develop our clinical research offering for industry partners.
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Contribute to studies combining clinical research, digital tools and patient-centred follow-up across several therapeutic areas.
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Work fully remotely from France, with regular travel related to the role.
Recruitment process
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One-on-one conversation with Elena — 20 minutes: discuss your motivation and fit for the role and Resilience’s culture.
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Interview with Charles Ferté, hiring manager — 30 minutes: explore your background, your vision for the role and your management style.
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Meet the medical team and clinical operations team members - 30 minutes/itw: discuss day-to-day collaboration. Participants and duration to be confirmed.
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Case study: a practical exercise related to the role, such as balancing a team’s workload across a study portfolio or estimating the cost of a study. Format, participants and duration to be confirmed.