Lead Clinical Data Manager

Job Summary

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:

• Bachelors or masters 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.