Senior Clinical Project Manager, Specimen Management

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $135.5k - $216.8k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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BD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

💰 $24M Grant on 2020-07

Healthcare Insurance • Pharmaceuticals • Science

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• 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. • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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