Sr. Clinical Project Manager (Specimen Management)

Senior Clinical Project Manager (Specimen Management)

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.

Working within the Medical Affairs organization, the Senior Clinical Project Manager (Specimen Management) is responsible for clinical trial management of multiple studies and may be subject matter authority for group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by Medical Affairs or Contract Research Organizations (CRO). The Senior Clinical Project Manager may also serve as mentor to other Clinical Project Managers. This role serves as the project 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. Reports to and collaborates with Clinical Portfolio Management to review business requests and evaluate or develop early plans and concepts for optimal study execution.

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

Education and Experience required:

• 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.

Knowledge and Skills required:

• 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.

Preferred qualifications:

• Advanced degree desirable (e.g., MS, MBA, PhD, MPH, PharmD, MD).
• PMP certification highly desirable.
• Experience in technical and/or medical writing desired.