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
Overview
The Manager, Clinical Operations (Specimen Management) is responsible for team management, clinical study management of multiple studies. This role may be a subject matter authority for group or platform of assigned clinical studies including the planning, implementation, project management and completion of clinical studies conducted by Medical Affairs or Contract Research Organizations (CRO).
The Manager, Clinical Operations, also serves as mentor and manager of Clinical Project Managers and/or Senior Clinical Project Managers. This role serves as the overall team lead for multiple studies of high complexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National and Local Regulations.
The Manager, Clinical Operations, provides strategic direction for clinical programs, collaborates with cross-functional team leaders on business requests, and evaluates or develops early plans and concepts for optimal study execution.
Responsibilities
Lead and develop a team of Clinical Project Managers, ensuring study teams consistently meet or exceed the timelines, quality standards and deliverables.
Establish team objectives, performance expectations, and development plans for Clinical Project Managers and monitor performance, ensuring alignment with Clinical Operations goals and organizational priorities.
Provide management oversight and reviews of study-related and essential study start-up documents to ensure quality, compliance and timely execution (e.g., Clinical Protocols, Informed Consent forms, Monitoring Plan, Clinical Product Management Plan, Clinical Safety Management Plan, Case Report Form [CRFs], CRF Completion Guidelines and other relevant documents).
Oversee and optimize allocation of study management resources.
Coach, mentor, and support the professional growth and career development of Clinical Project Managers and Senior Clinical Project Managers.
Provide oversight for the development and review of protocols, clinical study reports and other clinical study deliverables as applicable.
Lead continuous improvement initiatives that enhance study execution efficiency, quality, and compliance.
Support internal audits by leading and/or contributing to audit investigations, conducting root cause analyses, and overseeing the development and implementation of corrective and preventive action (CAPA) plans to ensure compliance and continuous improvement within the Clinical Project Manager team.
Foster and maintain strong collaborative relationships with sites/PIs, internal stakeholders, other study-related vendors, including CROs.
Apply advanced project management principles and methodologies to maintain integrated project plans (e.g., scope, time/schedule, cost/material and resources, quality, communication/escalation, risk, etc.), while facilitating key cross-functional discussions and decision-making.
Monitor, evaluate and report key performance indicators, study milestones and operational metrics from the Clinical Project Manager team.
Proactively identify, assess and mitigate study execution and compliance risks, ensuring appropriate escalation and resolutions are implemented.
Adapt study management deliverables based on study scale and complexity.
Requirements
Bachelor's degree required, preferably in life sciences, clinical or other relevant technical areas.
Minimum of 7 years of clinical study experience (pharmaceutical, medical device, IVD, biotechnology, or CRO), with proven ability to lead cross‑functional clinical teams in the planning, execution, oversight, and reporting of complex, global, multicenter studies—from initiation through closeout.
Demonstrate success leading complex clinical portfolios and Clinical Operations/Clinical Affairs initiatives. Strong knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulatory requirements.
Must have hands‑on experience managing the Trial Master File (TMF), ensuring accuracy, completeness, timeliness, and ongoing inspection‑readiness in compliance with ICH‑GCP and regulatory standards.
Proven ability to influence cross-functional teams without formal authority and collaborate with others to meet project goals, timelines, and/or deliverables.
Possesses strong financial acumen, including the ability to develop and maintain accurate project budgets, forecast financial needs, and provide strategic recommendations to enhance project performance and profitability.
Proven successful project management skills with meticulous attention to detail
Strong client and vendor relationship management skills.
Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment.
Exceptional written and verbal communication skills, with strong interpersonal, negotiation, and relationship‑management abilities to effectively engage a wide range of audiences and drive objectives.
Expert-level knowledge of clinical operations procedures, with the ability to resolve complex, cross-functional issues and influence outcomes beyond the immediate team.
Exceptional problem-solving, organizational, analytical, and critical thinking abilities, with a proven track record of delivering innovative solutions.
Proven ability to build strong relationships and communicate effectively across all organizational levels and with customers, fostering cross‑functional collaboration, proactively escalating issues, and leading joint initiatives to ensure timely resolution and project success aligned with strategic objectives.
Minimum of 2 years of people and team management experience highly preferred
Experience in technical and/or medical writing
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.
At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:
Annual Bonus
Health and Well-being Benefits
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Other Well-being Resources
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
Retirement and Financial Well-being
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Life Balance Programs
Paid time off (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Other Life Balance Programs
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Leave Programs
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave
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.
To learn more about BD visit https://bd.com/careers.
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.
Required Skills
Optional Skills
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Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
Work Shift
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Create bold but achievable resources and budget forecasts and timelines.
Collaborate with both internal and external representatives to provide strategic directions to assigned clinical program(s).
Provide oversight of the Trial Master File (TMF) activities performed by the Clinical Project Manager team to ensure TMF is complete, inspection-ready, and archived timely.
Ability to travel up to 30% domestically in the US and internationally.
Proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level Excel skills (Pivot Tables, VLOOKUP).
Proven ability to work effectively and collaboratively and lead a team in a remote environment.
