Lead Clinical Data Manager

Leica Biosystems Inc.; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Leica Biosystems Inc. is seeking an experienced clinical data management lead to drive data management activities across pre-market and post-market trials in Bengaluru, India. You will design CRFs, develop edit checks, and ensure clean databases for regulatory submissions.

The role requires a degree in science or health care and 6+ years in clinical data management, with up to 25% travel. Proficiency in Microsoft Access and Excel is preferred to support robust data workflows.

Qualifications

• Bachelor's or master's degree in science or health care area.
• 6+ years of experience in developing and executing clinical data management procedures.
• Occasional travel up to 25%

Responsibilities

• Responsible for all activities of clinical trial data management including CRF design, database and edit check development, query generation/processing, user acceptability testing, reconciliation of CRF and electronic data, and database cleaning activities.
• Plan and implement the data management portions of clinical research projects. Develops systems for organizing data to analyze, identify and report trends.
• Work with clinical leads, CRAs and statistical department to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams.
• Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
• Responsible for providing data management portions of clinical study reports, and participates in report review.

Skills

Clinical data management

Education

Bachelor's or master's degree in science or health care area

Tools

Microsoft Access

Excel

Job description

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

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
Within Danaher the work our diagnostic businesses do 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.
We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives.

Learn about the Danaher Business System which makes everything possible.

You will be a part of the Biostatistics and Data Management team and report to the Director of Biostatistics and Data Management, responsible for leveraging the Danaher Business System and tools in the timely and high-quality execution of a clinical data management strategy for pre-market and post-market trials. If you thrive in a collaborative and fast paced environment and want to work to build a world-class diagnostics organization—read on.

In This Role, You Will Have The Opportunity To

• Responsible for all activities of clinical trial data management including CRF design, database and edit check development, query generation/processing, user acceptability testing, reconciliation of CRF and electronic data, and database cleaning activities.
• Plan and implement the data management portions of clinical research projects. Develops systems for organizing data to analyze, identify and report trends.
• Work with clinical leads, CRAs and statistical department to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams.
• Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
• Responsible for providing data management portions of clinical study reports, and participates in report review.

The Essential Requirements Of The Job Include

• Bachelor's or master's degree in science or health care area
• 6+ years of experience in developing and executing clinical data management procedures and thorough knowledge of clinical research.
• 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
• General knowledge of FDA regulations
• Proficient with Microsoft Access and Excel
• Good understanding of medical terminology, human physiology and laboratory testing preferred

Within Danaher Diagnostics, we offer 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.