Job Description Summary

The successful Clinical Project Manager (PM) will participate in cross-functional project teams to plan and execute successful clinical studies, from concept through study completion, in support of corporate objectives. Additionally, the PM ensures that projects are completed on time, within budget, and in compliance with all regulatory requirements, Good Clinical Practice, & industry standards. The PM also provides oversight of the day-to-day activities of study team members and conducts personnel development and line management as needed.

Job Description

Responsibilities:

Under the direct supervision of the Director, Clinical Program Manager, and/or Sr. Clinical Project Manager, the PM will:

• 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 for submission to regulatory authorities

• 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

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

• Ensure that studies comply 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 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

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 in Clinical Research

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

• Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO 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

• Excellent communication skills (oral and written)

• Strong computer skills

• Proficiency with Microsoft Office Suite applications

• Strong interpersonal and organizational skills

• Ability to travel up to 40%  

Preferred Qualifications:

• Three (3) or more years of experience managing medical device studies

• Previous experience managing or mentoring personnel

• Previous site monitoring and/or CRA experience

• Therapeutic knowledge and/or experience with peripheral vascular devices for PAD, ESKD, and/or Oncology

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.

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Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift