As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.
We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job DescriptionClinical Database ProgrammerJob SummaryThe Clinical Database Programmer is responsible for the design, development, implementation, maintenance, and support of clinical databases and data management programming activities for clinical studies. This role ensures clinical trial data are collected, processed, validated, and delivered in accordance with applicable quality standards, regulatory requirements, and company procedures, resulting in high-quality, analysis-ready data.
The Clinical Database Programmer serves as a key technical resource within Clinical Data Management and works cross-functionally with Data Management, Statistics, Clinical Operations, Medical Affairs, and Information Technology teams to support the successful execution of clinical studies from study start-up through database lock and archival.
Essential Duties and ResponsibilitiesClinical Data Management Programming
- Lead and execute end-to-end clinical database programming activities for assigned clinical studies.
- Design, build, configure, test, and maintain electronic data capture (EDC) databases according to study requirements and approved specifications.
- Develop and implement edit checks, derivations, form logic, field dynamics, and other database functionality to support data quality and study objectives.
- Create, validate, and maintain data transfer specifications and external data integrations.
- Perform loading, reconciliation, and processing of non-CRF data from external sources.
Study Execution and Data Quality
- Partner with study teams to define data collection requirements and ensure alignment with protocol objectives and regulatory expectations.
- Enforce data standards, data integrity principles, and quality expectations throughout the clinical data lifecycle.
- Review and provide input on data management plans, study documents, CRFs, edit check specifications, and related study documentation.
- Support study milestones by ensuring timely delivery of complete, accurate, and reliable clinical data.
- Contribute to database lock activities and support inspection and audit readiness as required.
Reporting and Technical Support
- Develop, test, and maintain reports, listings, dashboards, and data review tools using SQL, SAS, or other reporting technologies.
- Utilize data analytics and reporting solutions to facilitate data review, issue identification, and study oversight.
- Troubleshoot database and data management programming issues and collaborate with IT and system vendors to implement solutions.
- Serve as a technical subject matter expert for clinical database programming and EDC functionality.
Cross-Functional Collaboration
- Establish and maintain effective working relationships with cross-functional stakeholders involved in clinical study execution.
- Communicate study progress, risks, and technical considerations to project teams and management.
- Provide guidance and mentorship to other team members as appropriate.
- Participate in process improvement initiatives and contribute to the advancement of data management standards, tools, and best practices.
Continuous Improvement
- Identify opportunities to improve efficiency, quality, and consistency across clinical data management programming processes.
- Support implementation of new technologies, methodologies, and industry best practices.
- Contribute to departmental initiatives and organizational goals related to clinical systems and data management.
Education and ExperienceRequired Qualifications- Bachelor's degree in Computer Science, Life Sciences, Information Systems, Mathematics, Statistics, or a related field; or an equivalent combination of education and relevant experience.
- Minimum of 3 years of clinical database programming or clinical data management experience within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) industry.
- Experience supporting clinical studies from database build through database lock and archival.
- Experience with Veeva CDMS, Veeva EDC, or equivalent electronic data capture platforms.
Knowledge, Skills, and Abilities- Strong understanding of clinical trial processes, data management principles, and clinical data lifecycle activities.
- Knowledge of FDA, ISO, ICH-Google Cloud Platform, and applicable regulatory requirements governing clinical research and data management.
- Understanding of relational database design and data structures.
- Proficiency in SQL programming and data extraction techniques.
- Experience with EDC systems, preferably Veeva CDMS.
- Familiarity with MedDRA and WHO Drug coding dictionaries.
- Strong analytical, problem-solving, and troubleshooting skills.
- Ability to manage multiple priorities and meet project timelines in a fast-paced environment.
- Excellent written and verbal communication skills.
- Effective collaboration and stakeholder management skills within cross-functional teams.
- Proficiency with Microsoft Office applications and clinical research technologies.
Physical Requirements- Ability to remain in a stationary position for extended periods of time.
- Frequent use of a computer, keyboard, and other office equipment.
- Ability to communicate effectively through written and verbal means.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.
Work Environment- Hybrid or remote work environment.
- Occasional travel up to 10% may be required based on business needs.
At Waters, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles. employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
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Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
Additional LocationsWork ShiftAt BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
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