Sr Clinical Project Manager

6206 Augusta Life Sciences US OpCo I LLC; Maryland; On-site; USD 118,000 - 189,000; Full time

Benefits offered by this job

Health & Well-being

Retirement & Financial Well-being

Work-Life Balance & Family Support

Leave Programs

Job summary

Waters is seeking a leader to manage complex IVD clinical studies within regulated environments. You will shape study protocols, safety plans, and regulatory submissions, coordinating with vendors and cross-functional teams to deliver on time and within budget.

The role emphasizes strong project management, communication, and the ability to work with external sites and KOLs to ensure high-quality study deliverables and adherence to global regulations.

Qualifications

• Degree level qualification.

Responsibilities

• Lead all aspects of planning and execution of complex IVD clinical studies with timelines and budgets.
• Develop clinical study protocols, informed consent forms (ICFs) and case report forms (CRFs).
• Ensure compliance with FDA, ISO, GCP and Waters policies; manage vendors and cross‑functional teams.

Education

Degree level qualification

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purpose 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.

Job Description Responsibilities

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).

Minimum Requirement

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.

Why Join Us

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Primary Skills & Location

Required Skills Optional Skills . Primary Work Location USA MD - Sparks - 7 Loveton Circle Additional Locations Work Shift

Benefits

• Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.
• Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.
• Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.
• Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.

Additional details regarding benefits and well-being programs can be found in Our Commitment to You.

Salary Range Information

Salary Range Information $117,800.00 - $188,600.00 USD Annual

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.