Sr Clinical Project Manager

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.

• →Lead all aspects of the planning and execution of complex 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 safety plans
• →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 Waters 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
• →Monitoring, evaluating, and managing the safety of study participants throughout the trial.
• →Demonstrate understanding of Business Unit 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
• →Excellent time management skills, with demonstrated ability for self-direction and initiation.
• →Must be able to manage multiple tasks simultaneously and have excellent communication and project management skills
• →Prepare and present reports on clinical trial progress to key stakeholders.
• →Strong oral and written communication skills, and ability to work independently.
• →Demonstrated ability to work well with other professionals with minimal supervision 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).

• Degree level qualification; or equivalent combination of education and experience.

 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