Senior Clinical Data Manager
Clinical Data ManagementBachelor RequiredSenior
About the role
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.
Requirements
- 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.
- Occasional travel up to 25%
Desired Experience
- 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
About IDBS
IDBS helps BioPharma organizations unlock the potential of AI/ML to improve the lives of patients. As a trusted long-term partner to 80% of the top 20 global BioPharma companies (1), IDBS delivers powerful cloud software and services specifically designed to meet the evolving needs of the BioPharma sector. IDBS, a Danaher company, leverages 35 years of scientific informatics expertise to help organizations design, execute and orchestrate processes, manage, contextualize and structure data and gain valuable insights throughout the product lifecycle, from R&D through manufacturing. Known for its signature IDBS E-WorkBook software, IDBS has extended its flexible, scalable solutions to the IDBS Polar and PIMS cloud platforms to help scientists make smarter decisions with assured confidence in both GxP and non-GxP environments. 1. Rank measured by Market Cap, Q1 2024. Learn more about: - IDBS E-WorkBook: https://www.idbs.com/products/e-workbook/ - IDBS Polar: https://www.idbs.com/polar/ - IDBS PIMS: https://www.idbs.com/skyland-pims/ IDBS is proud to be part of Danaher, a global life sciences and diagnostics innovator committed to accelerating the power of science and technology to improve human health. As part of Danaher, IDBS is connected to a uniquely broad ecosystem of expertise, technologies, and capabilities. Together, we partner closely with customers to solve their toughest challenges with greater speed and certainty. Powered by the rigor of the Danaher Business System and a culture of continuous improvement, we make time a competitive advantage for our customers and help unlock the transformative potential of science and technology to improve billions of lives every day.