Clinical Data Manager

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 management skills.

Ability to work independently with minimal supervision

Preferred Skills / Experience :

Bachelor 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

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 at BD, 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?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

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 health.