Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology

At Cepheid, one of 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.

Learn about the which makes everything possible.

The LeadClinical 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 positionreports to theClinical Affairs Manager, Global QRC On-market Sustainment and willbeanon-siterolein 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.

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