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BD (Becton, Dickinson and Company) Senior Clinical Affairs Project Manager (remote) in Franklin Lakes, New Jersey

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The role of Global Clinical Affairs (GCA) as part of the Medical Affairs organization is to provide any services in human subject research where needed globally. Ensuring quality study execution to meet regulatory and commercial goals, in the desired, and/or most cost-effective geography. GCA supports all Business Units within BD and is therefore involved in the execution of clinical studies with a broad range of products. GCA provides support for study execution, data management, statistics and medical writing.

Our people make all the difference in our success.

The successful Senior Clinical Project Manager (Sr. CPM) will participate in cross-functional project teams to plan and execute successful clinical studies, from concept through study completion, in support of corporate objectives. The Sr. CPM also provides oversight of the day-to-day activities of study team members and conducts personnel development and line management as needed.

Responsibilities:

  • Oversee the planning and execution of clinical studies, including clinical study timeline development, to ensure that deliverables are completed on time and within budget

  • Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents

  • Develop clinical study reports (CSRs) for submission to regulatory authorities

  • Support regulatory submission activities globally where clinical study data is needed to show product safety and efficacy

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

  • Oversee and review deliverables produced by study team members to ensure quality and compliance

  • Select and manage external vendors to ensure that trials completed on-time, within budget, and are consistent with the scope of work

  • Ensure that studies align with BD policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations

  • Demonstrate understanding of BD’s general business functions, products, and procedures and serve on cross-functional project teams as a clinical subject matter expert

  • Develop and implement standardized processes and operating procedures for conducting clinical research

  • Supervise department personnel as needed

  • Create and maintain clinical study documents as part of the trial master file (TMF)

  • Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants

  • Conduct on-site and/or remote clinical monitoring activities as needed

  • Lead and actively participate in various cross functional team meetings

  • Effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded

  • Collaborate with Business Unit Medical Affairs team and other BU stakeholders

Required Qualifications:

  • BA/BS (MA/MS preferred) in health science field or equivalent combination of training and experience

  • Five (5) or more years of experience managing clinical research studies, including complex, global multi-center studies including site monitoring and/or CRA experience (three (3) or more years of experience managing medical device studies preferred)

  • Seven (7) or more years of experience in Human Subject Research

  • Therapeutic knowledge and/or experience with surgical products and devices for hernia, soft tissue repair, infection prevention, biosurgery and/or breast reconstruction preferred

  • Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO guidelines and regulations, and current industry practices related to the conduct of clinical studies

  • Ability to work independently, manage multiple projects and personnel in a fast-paced environment, and effectively navigate obstacles

  • Ability to work effectively in a virtual environment

  • PMP certification is a preferred goal for all Clinical Project Managers

  • Observation experience in the OR is a plus

Work Environment / Travel

  • Remote US based role - preference is for candidate near BD Franklin Lakes NJ (if not travel will be required 1 x per quarter to this site)

  • Travel required domestically (and possibly internationally): total travel is 25-40% when clinical trials site visit become possible.

​Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19.  Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

#LI-PRO

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA AZ - Tempe Headquarters, USA CA - San Diego Bldg A&B, USA CA - San Jose, USA FL - Miami, USA MO - St Louis, USA NC - Research Triangle Park, USA TX - San Antonio

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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