Job Description Summary

The Clinical Data Manager is responsible for performing end-to-end Data Management activities for assigned studies. The Clinical Data Manager ensures that clinical study data is collected, processed, and validated in a consistent and appropriate manner that is consistent with BD’s QMS procedures, resulting in high quality data ready for statistical analysis within the project timelines.

This position also serves to contribute to process improvement, staff learning and development.

Job Description

We are the makers of possible 

 

BD 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. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

The Clinical Data Manager is responsible for performing end-to-end Data Management activities for assigned studies. The Clinical Data Manager ensures that clinical study data is collected, processed, and validated in a consistent and appropriate manner that is consistent with BD’s QMS procedures, resulting in high quality data ready for statistical analysis within the project timelines.

Responsibilities

• Review and provide feedback on study Clinical Investigation Plan (CIP)/Clinical Performance Study Protocol (CPSP) to ensure the data collection requirements are clear.

• Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more studies.

• Efficiently plans, coordinates, and delivers complete, high quality and reliable, clinical trial data in a timely manner for assigned projects.

• Responsible for end-to-end clinical data management activities and serves as a primary point of contact for team members.

• Provides strong quality and project oversight over third party vendors responsible for data management deliverables.

• Enforces data standard conventions and quality expectations for clinical data per defined processes.

• Authors, reviews/revises 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.

• Coordinates, participates and complete database User Acceptance Testing (UAT) and related tasks.

• Represents 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 the 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.

• Provides mentorship and training to junior Data Management staff.

• Ability to travel up to 5%.

Required Skills/Experience:

• 3+ years direct, Clinical Data industry experience required.

• Demonstrated leadership quality and advanced organizational and interpersonal skills.

• Detail oriented with advanced written and verbal communication skills and experience working in 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 manag