Job DescriptionOverviewThe 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.
- 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.
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.
- 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.
Preferred Qualifications- Advanced degree highly desirable (e.g., MS, MBA, PhD, MPH, PharmD, MD)
- PMP certification
- 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.
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:
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
Required Skills
Optional Skills
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsWork ShiftAt 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.
Salary Range Information$137,500.00 - $220,100.00 USD Annual
