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Senior Clinical Quality Compliance Specialist
Dexcom
Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the companys inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific.
We invite you to become a part of a fast growing, purpose driven team in our new established business centre in Vilnius!
Summary:
As a Senior Clinical Quality Compliance Specialist, you will be responsible for overseeing various aspects of quality management within the organization, with a focus on clinical operations. You will play a critical role in ensuring adherence to regulatory standards, maintaining high-quality standards, and fostering a culture of continuous improvement. You will collaborate cross-functionally with various departments to drive clinical quality initiatives and support the company's objectives.
About the Role:
- Proactively liaison with clinical trial managers, clinical program managers, and study teams to foster an environment of quality-oriented trial execution
- Ensure efficient oversight and execution of Document Management and Control processes
- Coordinate Corrective and Preventative Action (CAPA) system oversight for clinical affairs
- Monitor industry trends and engage with operational teams to proactively implement best practices and ensure inspection readiness
- Clinical quality point of contact for internal, regulatory, and investigator audits and serves as an auditor on both internal audit and supplier audit teams
- May perform routine or for-cause clinical site audits, as necessary
- Review data to identify trends and implement appropriate process improvement strategies
- Foster a collaborative working relationship with other functional areas.
About You:
- Thorough understanding of ISO Standards, ICH Guidelines, GCP, and FDA regulations
- Operate with a high degree of ethics
- Meet key deadlines and manage multiple projects and tasks simultaneously
- Write and communicate articulately and concisely
- Work proactively, take initiative and ownership, and assess risk
- 5+ years of clinical trials experience in the clinical/biotechnology field
- 3+ years of experience in a clinical quality assurance position requiring oversight of GCP regulations
- Experience with reviewing and/or drafting GCP related documents such as SOPs and protocols
- Familiarity with continuous glucose monitoring devices and diabetes management is a plus.
- You don't mind adjusting your work hours to facilitate effective collaboration with team members in different time zones, including regular participation in meetings during US East and West Coast business hours.
We Offer:
- Opportunity to work in a global, innovative, fast-growing company.
- Flexible work.
- 5 additional vacation days.
- Health, Life and Accident insurance.
- Health and Wellness programs.
- Private Pension plan.
- Access to the best-in-class training and development programmes.
- Team buildings and events.
- Competitive salary and additional bonuses.
Sounds like you? Apply!
Monthly base salary for this position is from € 3833,00 gross. Final offer will depend on your qualifications, competencies, and professional experience.
€
3833
Additional information: Final offer will depend on your qualifications, competencies, and professional experience.
Location
- Vilnius, Vilniaus apskritis, Lithuania
- Remote work opportunity
Time of work
- Full-time
Languages
- English
Contact person
Jurgita Stikliūnė
Jurgita Stikliūnė
Founded in 1999, Dexcom empowers people to take control of their diabetes through innovative continuous glucose monitoring systems. By listening to the needs of users, caregivers and healthcare providers, Dexcom simplifies and improves diabetes management around the world. Headquartered in San Diego, California, with additional offices in the U.S., Europe, and Asia Pacific.
Vilnius Global Business Services centre supports Dexcom operations and its customers across the EMEA region and will expand the company's patient support, customer advocacy, finance and accounting operations in Europe.
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