Job details

Associate Clinical Project Manager (Remote)

Job Description Summary

Essential / Key Job Responsibilities (including supervisory and/or fiscal):
Under the direct supervision of the Principal Clinical Project Manager, the Associate CPM 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
Recognizes potential problems, takes preventive steps, and recommends solutions.
Demonstrate understanding of BD’s general business functions, products, and procedures and serve on cross-functional project teams as a clinical study subject matter expert
Develop and implement standardized processes and operating procedures for conducting clinical research
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
Ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded
Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States)

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 creativity 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 and find ground-breaking solutions that turn dreams into possibilities.

We believe that the element, across our 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 with us.

Responsibilities:

Lead all aspects of the planning and execution of clinical studies, including study timeline development, to ensure that results are completed on time and within budget.
Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other crucial clinical study documents.
Develop clinical study reports for submission to regulatory authorities.
Develop and supervise the clinical study budget, including invoice review/approval and monthly accruals.
Be responsible for and review results produced by study team members to ensure quality and compliance.
Lead vendors to ensure that results are 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.
Recognizes potential problems, takes preventive steps, and recommends solutions.
Demonstrate understanding of BD’s general business functions, products, and procedures and serve on cross-functional project teams as a clinical study subject matter authority.
Develop and implement standardized processes and operating procedures for conducting clinical research.
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.
Ability to efficiently prioritize tasks and responsibilities and ensure project milestones & deliverables are met or exceeded.
Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States).

Required Qualifications:

Two or more years of experience in Clinical Research.
One or more years of experience handling clinical research studies
Strong proven understanding of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studies.
Ability to work independently on most activities, handle multiple projects and personnel in a fast-paced environment, and effectively navigate obstacles.
Excellent communication skills (oral and written).
Strong digital literacy.
Proficiency with Microsoft Office Suite applications.
Strong communication skills.
Ability to travel up to 10-20%.

Preferred Qualifications:

Three (3) or more years of experience leading medical device studies.
Previous experience leading or mentoring personnel.
Previous site monitoring and/or CRA experience.
Therapeutic knowledge and/or experience with infectious disease diagnostics including molecular or immunoassay platforms.

Education and/or Experience:

BA/BS (MA/MS preferred) in health science field or other relevant technical area or equivalent combination of training and experience. Professional certification (clinical research, laboratory) is a plus.
Minimum one year experience in clinical project management.

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 excellent, we do what’s right, we hold each other accountable, and learn and improve 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 exciting culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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 creativity and aim to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

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

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.

PDN

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