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At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
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The Lead Clinical Data Manager is responsible for ensuring the accuracy, completeness and integrity of data collected during IVD clinical trials. The CDM is responsible for developing the clinical data management plan for pre-market and post-market clinical trials and timely execution of the plans throughout the lifecycle of the study.
This position reports to the Clinical Affairs Manager, Global QRC On-market Sustainment and will be an on-site role in Bengaluru, India.
In this role, you will have the opportunity to:
Develop clinical study data management plans and provide clinical data management support for clinical teams, study projects, and biostatistics, including execution of data management plans across the full study lifecycle.
Develop case report forms (or eCRF), clinical trial data specifications, EDC database specifications, user requirements, edit rules/checks, query logic and data validations.
Define and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
The essential requirements of the job include:
Bachelor's or master's degree in science or health care area
5+ years of experience in developing and executing clinical data management procedures and thorough knowledge of clinical research.
Experience with executing database lock, freeze, close-out audits and archival activities for a clinical trial; manage external data transfers by developing data transfer agreements, reconciling electronic data transfers, generating data listings, validating summary tables, and preparing datasets for statistical review and audit readiness.
Demonstrate proficiency with user acceptance testing following database upgrades or migrations, EDC user management across clinical trials, and creation of user guides for EDC training.
Understand data system compliance by following the established guidelines of regulatory authorities.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Occasional travel up to 25%
It would be a plus if you also possess previous experience in:
Experience in in-vitro diagnostics (IVD), Pathology, and Companion Diagnostics clinical research
Demonstrated ability to explain complex or sensitive information to diverse audiences, including senior leaders; excellent organizational skills and ambition to continuously improve together with the business
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
Skills Required
- Bachelor's or master's degree in science or health care area
- 5+ years of experience in developing and executing clinical data management procedures and knowledge of clinical research
- Experience executing database lock, freeze, close-out audits, archival activities, and preparing datasets for statistical review and audit readiness
- Experience managing external electronic data transfers, developing data transfer agreements, reconciling transfers, and generating data listings/validations
- Proficiency with user acceptance testing after database upgrades or migrations, EDC user management, and creating EDC user guides
- Understanding of data system compliance with regulatory authority guidelines
- Experience in in-vitro diagnostics (IVD), Pathology, and Companion Diagnostics clinical research
- Ability to explain complex information to diverse audiences, including senior leaders; strong organizational and continuous improvement mindset
Danaher Corporation Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.
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Healthcare Strength — Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
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Retirement Support — Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
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Parental & Family Support — Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.
Danaher Corporation Insights
What We Do
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.
