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Dexcom

Empowering people to take control of health

Senior Clinical Study Manager

ManagerManagerFull TimeRemoteLeadTeam 10,001+Since 1999H1B SponsorCompany SiteLinkedIn

Location

EMEA

Posted

2 days ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Senior Clinical Study Manager

Dexcom

Role Description As a Senior Clinical Trial Lead, you will oversee the operational delivery of multi-country medical device clinical investigations across Europe. This role encompasses planning, execution, and closeout in full compliance with ISO 14155, EU MDR 2017/745, ICH-GCP, GDPR, and applicable local regulations. Acting as the single point of accountability for trial quality and performance, the Sr. CTL provides strategic direction, operational leadership, and cross-functional coordination from study initiation through completion. Where you come in: - Lead cross-functional trial teams (Site Management, Monitoring, Data Management, Biostats, Safety, Clinical Logistics). - Drive country and site feasibility across Europe and select sites based on clinical trial design requirements. - Author, review, and approve clinical study protocols and informed consent forms to ensure scientific integrity, regulatory compliance, and ethical standards. - Ensure protocol adherence, timely data entry, query resolution, and deviation management. - Coordinate with ethic committees and competent authority as needed. - Maintain inspection-ready documentation, drive continuous improvement and lessons learned. - Serve as the central point of contact for internal/external stakeholders. - Prepare updates, risk summaries, and decision briefs to senior leadership. - Develop timeline plans and proactively manage path to meet trial milestones (e.g. FPI). - Provide robust vendor oversight (e.g. CROs), escalate and remediate as needed. - Lead and drive strategic initiatives, coordinating cross-functional teams to ensure timely and high-quality execution. Qualifications - Experience in leading a clinical trial in all phases (e.g. start up, execution, and close out). - Experience in medical devices and/or diabetes clinical trials. - Proficient at utilizing clinical management systems and electronic data capture systems. - Prior inspection/audit participation. - Familiar with post market clinical follow-up, registries, real-world evidence, or adaptive designs. - Detail-oriented, strategic thinker, problem solver, and drive decision making. - Excellent communication both verbal and written. Requirements - Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or a Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience. Benefits - A front row seat to life changing CGM technology. - Learn about our brave #dexcomwarriors community. - A full and comprehensive benefits program. - Growth opportunities on a global scale. - Access to career development through in-house learning programs and/or qualified tuition reimbursement. - An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Remote Workplace Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically within an hour’s commute). If you reside within commuting distance of a Dexcom site, a hybrid working environment may be available. Ask about our Flex/Hybrid workplace option.

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