Job Description Summary

The Clinical Project Manager (CPM) will lead cross-functional study teams to plan and execute successful clinical studies, from concept through study completion.

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. 

Job Summary

The Clinical Project Manager will be responsible for handling all clinical studies of the assigned Therapeutic Area(s) (TA), in accordance with applicable regulations, company SOPs and ICH GCP principles. The role includes oversight of multiple clinical trials of varying complexity at different sites across the US and globally. This role will serve as the clinical study lead from protocol development through study conduct and closeout. The position will report directly to the Director, Clinical Affairs.

Responsibilities

• Overall management of multiple clinical studies in compliance with internal and external standards

• Develop study protocols/amendments and acquire IRB approval

• Prepare and/or review study-related plans and crucial documents (e.g., Informed Consent

• Forms, Clinical Study Management Plan, Regulatory Plan, Study Process Risk Assessment, Source

• Documents, Case Report Forms (CRFs)).

• Follow established project management standards to develop and maintain study project plans

• (scope, time/schedule, key achievements, cost/material and human resource, quality, communication/critical issue, risk)

• Develop and track the clinical study budget, including invoice review/approval and monthly accruals

• Supervise and review results produced by study team members to ensure quality and compliance Interact with investigators and site staff on study related issues

• Coordinate, qualify and lead external clinical suppliers supporting UCC studies (e.g., Central IRB, CRO, clinical software provider, etc.)

• Train new team members and clinical site personnel, as appropriate

• Conduct on-site visits and monitoring activities as needed

• Develop Clinical Investigation Reports (CIRs) upon study completion for submission to regulatory authorities (as applicable) and IRBs

Qualifications

• BA/BS in a health science field with >5 years relevant experience OR MA/MS in a health science field with >2 years relevant experience

• Three (3) or more years of experience handling clinical research studies

• Solid understanding of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studies

• Solid understanding of clinical trial planning, management, and metrics

• Ability to work independently, lead multiple projects and study teams in a fast-paced environment, and optimally navigate challenges

• Excellent social skills and ability to interact expertly with physicians and scientists

• Strong communication skills (oral and written)

• Computer proficiency including Microsoft Office Suite and advanced database applications

• Ability to travel approximately 10%-20%

At BD, 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 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.