Note: The job is a remote job and is open to candidates in USA. BD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Senior Clinical Project Manager (Specimen Management) is responsible for managing clinical trials, overseeing project execution, and mentoring other Clinical Project Managers while ensuring compliance with regulatory standards.
Responsibilities
- Works without appreciable supervision and direction, Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (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)
- Serves as a Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team
- Oversees/leads study-specific study management resources
- Develops and manages group of studies for an entire business unit or large development program
- Mentors other Clinical Project Managers
- Provides critical thinking and leadership when issues arise during execution of clinical studies
- Writes protocols, clinical study reports and other clinical study deliverables as applicable
- Leads or gives to continuous improvement activities/initiatives
- Handles relationships with sites/PIs, other study related vendors, including CROs
- Intermediate knowledge, of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resources, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed
- Defines, tracks and reports schedule attributes such as durations, interdependencies, achievements, critical path and other key deliverables including efficiency and effectiveness of plans and staff
- Adapts work package deliverables based on study scale and complexity
- Creates bold but achievable resource and budget forecasts and timelines
- Interacts with both Internal and External representatives, providing direction to the cross functional team members and vendors (if applicable) regarding the technical, protocol-specific and operational aspects of assigned studies
- Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost-effective and timely delivery of the project including critical issues if needed
- Plans and maintains high quality standards to meet compliance requirements
- All other duties as assigned
Skills
- Bachelor's degree, preferably in the life sciences, clinical or other relevant technical areas
- Minimum of 5 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
- Minimum of 5 years project management experience, preferably using MS Project
- 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
- Strong leadership skills with the ability to inspire teams and drive meaningful change across the organization
- 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 in a remote environment
- Ability to travel approximately 20%, should reside near a major airport to facilitate travels
- Advanced degree desirable (e.g., MS, MBA, PhD, MPH, PharmD, MD)
- PMP certification highly desirable
- Experience in technical and/or medical writing desired
Benefits
- Annual Bonus
- 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
- 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
- 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
- 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
- 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
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
Company Overview
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions. It was founded in 1897, and is headquartered in Franklin Lakes, New Jersey, USA, with a workforce of 10001+ employees. Its website is https://www.bd.com.Company H1B Sponsorship
BD has a track record of offering H1B sponsorships, with 66 in 2023, 4 in 2022, 3 in 2021. Please note that this does not guarantee sponsorship for this specific role.