NHS Human Services, Inc.

Job Description Summary

The successful Clinical Project Manager (CPM) will have a lead role in study design and management reporting to the Principle of Clinical Projects/Sr. Clinical Project Manager or Manager, Clinical Affairs. Clinical studies may range from simulated use studies to studies involving human subjects and/or specimens that include in vitro diagnostics (IVDs).

The CPM serves as a study and project manager for studies of moderate to high complexity from protocol development through study conduct and study closeout in compliance with Good Clinical Practices, and all National and Local Regulations.

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.

Responsibilities

Under the direct supervision of the manager, the CPM will:

• Lead all aspects of the planning and execution of IVD 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 essential clinical study documents.

• Develop clinical study reports for submission to regulatory authorities.

• Develop and track clinical study budgets, 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.

• Recognize potential problems, take preventive steps, recommend solutions, and track lessons learned.

• 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.

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

• Must be able to manage multiple tasks simultaneously and have excellent communication skills.

• Prepare and present reports on clinical trial progress to key stakeholders.

• Strong oral and written communication skills.

• Demonstrated ability to work well with other professionals and be comfortable being part of a diverse professional team.

• Responsible for timely creation and maintenance of clinical study registration updates (clinicaltrials.gov or global registrations for clinical studies conducted outside of the United States)

Education and Experience:

• BA/BS (MA/MS preferred) in health science field or other relevant technical area or equivalent combination of training and experience in lieu of a bachelor's degree. Professional certification (clinical research, laboratory) is a plus.

• Minimum 3 years of experience in clinical research.

• Project management skills required to include the use of a formal process and system for planning and tracking ongoing progress of clinical projects.

• Proficiency with MS Project highly desired.

• Knowledge and experience of Good Clinical Practice (GCP) and ICH requirements required. Knowledge of additional/local regulations a plus.

• Vendor management experience desired.

Knowledge and Skills:

• Three (3) or more years of experience with IVD clinical research studies from study planning to study closeout.

• One (1) or more years of experience handling POC CLIA waiver studies from planning to study closeout

• Ability to build and maintain effective relationships with trial sites staff and colleagues.

• Previous experience leading or mentoring personnel.

• Previous site monitoring and/or CRA experience.

• Therapeutic knowledge and/or experience with infectious disease diagnostics including microbiology, molecular or immunoassay platforms.

• Experience in IVD research and development, clinical laboratory (molecular, microbiology, hematology) may be considered in lieu of desired clinical research experience.

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. 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

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

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.