Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. The Senior Clinical Data Manager for Beckman Coulter Diagnostics is responsible for technical and day-to-day application support the clinical data management needs for our clinical studies which follow GCP and FDA requirements.This position is part of the Clinical Affairs organization and will be an onsite position in either Chaska, MN or Miami, FL.You will be a part of the Data Management Team and report to the Senior Staff Data Manager responsible for supporting data management project needs and activities to ensure that applicable policies, procedures, and regulatory standards are followed.In this role, you will have the opportunity to:
Lead development of the clinical data management documentation for clinical studies using electronic data capture methods, data management plans, CRF designs, data dictionaries, data validations, data specifications, acceptance criteria, and data transfer agreements.
Execute clinical data management activities throughout study lifecycle, such as supporting site initiation activities, reconciling electronic data transfers, validating data quality, preparing data for statistical review and/or data management audit, performing database lock and freeze activities, coordinating the archiving of study databases and related documents, and performing close out audits.
Serve as liaison with Clinical Affairs to ensure robust data transfer and data quality processes are implemented and followed such as data acceptance criteria and data transfers.
Develop database clinical trial data specifications and ensure compliance throughout study lifecycle, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
Collaborate with study team members within data management, data automation, biostats and clinical affairs to execute study activities, improve processes, and generate novel solutions where required.
The essential requirements of the job include:
Bachelor’s degree 5+ years relevant experience or Master’s degree with 3+ years of experience or Doctoral degree with 0-2 years of experience in Computer Science, Mathematics, Statistics, Pharmaceuticals Sciences, Life Sciences or related fields.
Knowledge of EHR and EDC (Medidata Rave is a plus) data sources, clinical data management roles and activities, such as developing and executing clinical data management documentation, developing study dataset specifications, working with CDISC, etc.
Proficient in Excel, communication, executing trainings, data presentation, problem solving, and professional writing (data management plans, procedure, work instructions, etc.).
Previous work experience in a diagnostic, medical device or pharmaceutical fields.
It would be a plus if you also possess previous experience in:
Experience using a high-level programming language such as R, Python, SQL for complex data analysis and reproducible research practices.
Understanding of validation requirements for software tools.
Knowledge and programming skills in Medidata Rave.
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 . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
Full-time