Job Description

The Clinical Data Manager is responsible for performing end-to-end Data Management activities for assigned studies and ensuring that clinical study data is collected, processed, and validated in a consistent manner with BD’s QMS procedures, resulting in high‑quality data ready for statistical analysis within project timelines. Responsibilities Review and provide feedback on study Clinical Investigation Plan (CIP)/Clinical Performance Study Protocol (CPSP) to ensure data collection requirements are clear. Provide clinical data management leadership within the study team to align on and drive data collection requirements for one or more studies. Efficiently plan, coordinate, and deliver complete, high‑quality, and reliable clinical trial data in a timely manner for assigned projects. Serve as the primary point of contact for team members for end‑to‑end clinical data management activities. Provide strong quality and project oversight over third‑party vendors responsible for data management deliverables. Enforce data standard conventions and quality expectations for clinical data per defined processes. Author, review, and revise data management related study documents and plans—including Data Management Plan (DMP), Data Management Report (DMR), electronic Case Report Forms (eCRFs), Database Configuration Specifications (DCS), External Data Specifications (EDS), eCRF Completion Guidelines, and other study documents—to ensure quality and standardization. Coordinate and complete database User Acceptance Testing (UAT) and related tasks. Represent Data Management on cross‑functional project teams. Review and validate clinical study data to ensure consistency, accuracy, integrity, and completeness. Provide project metric reports, status updates, study progress, feedback, and advice to project teams on site performance issues and data trending. Manage database implementation, lock, and close‑out processes and procedures in accordance with established processes. Maintain study documentation on an ongoing basis and ensure that all documentation and filing is inspection‑ready. Provide mentorship and training to junior Data Management staff. Travel up to 5% as needed. Required Skills and Experience 3+ years of direct clinical data industry experience. Demonstrated leadership quality and advanced organizational and interpersonal skills. Detail oriented with advanced written and verbal communication skills and experience working in a cross‑functional setting. Fundamental knowledge of device development process, FDA/ISO guidelines and industry standard practices regarding data management. Experience with clinical data lifecycle from database set‑up and maintenance to database lock and archiving. Competent in Excel and/or SAS programming. Good knowledge and experience of EDC systems (Veeva preferred); demonstrated knowledge of Microsoft Office skills. Multidisciplinary knowledge across functional areas in clinical research. Ability to work collaboratively on multi‑disciplinary project teams and develop productive relationships. Fundamental project management skills. Ability to work independently with minimal supervision. Preferred Skills and Experience Bachelor’s degree preferred. Physical Demands Ability to sit/stand in the same position for long periods of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Salary Range $84,300.00 – $138,900.00 USD Annual 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. #J-18808-Ljbffr BD

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