Senior Clinical Project Manager, Specimen Management

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• The Senior Clinical Project Manager (Specimen Management) operates within the Medical Affairs organization, overseeing the management of multiple clinical trials. This role may also serve as a subject matter expert for a group or platform of assigned clinical studies, encompassing the planning, execution, oversight, project management, and completion of clinical trials conducted either by Medical Affairs or Contract Research Organizations (CRO).

• This position may also act as a mentor to other Clinical Project Managers.

• The individual will lead multiple complex studies from protocol development to study conduct and closeout, ensuring compliance with Good Clinical Practices and all applicable Global, National, and Local Regulations.

• The role involves reporting to and collaborating with Clinical Portfolio Management to assess business requests and develop early plans and concepts for optimal study execution.

• The Senior Clinical Project Manager works independently, preparing and/or reviewing study-related documents essential for the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Monitoring Plan, Clinical Product Management Plan, Clinical Safety Management Plan, Case Report Forms (CRFs), CRF Completion Guidelines, and other pertinent documents).

• As a Clinical Project Manager, this role ensures that the Study Management team meets or surpasses the timelines and deliverables assigned to the study team.

• The individual will oversee and lead study-specific management resources.

• The role involves developing and managing a group of studies for an entire business unit or a large development program.

• Mentorship of other Clinical Project Managers is also a key responsibility.

• The Senior Clinical Project Manager will provide critical thinking and leadership when challenges arise during the execution of clinical studies.

• Responsibilities include writing protocols, clinical study reports, and other relevant clinical study deliverables as necessary.

• This position leads or contributes to continuous improvement initiatives and activities.

• The role includes managing relationships with sites/PIs and other study-related vendors, including CROs.

• A solid understanding of established project management standards is required to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resources, quality, communication/escalation, risk, value) and to organize/facilitate meetings and discussions as necessary.

• The individual will define, track, and report on schedule attributes such as durations, interdependencies, achievements, critical path, and other key deliverables, including the efficiency and effectiveness of plans and staff.

• Work package deliverables will be adapted according to the scale and complexity of studies.

• The Senior Clinical Project Manager will create ambitious yet achievable resource and budget forecasts along with timelines.

• Interaction with both Internal and External representatives is necessary, providing guidance to cross-functional team members and vendors (if applicable) regarding the technical, protocol-specific, and operational elements of assigned studies.

• Proactively identifying and managing risks and issues (including maintaining a log, mitigations, and contingencies) is essential to ensure the cost-effective and timely delivery of the project, particularly for critical issues when necessary.

• The individual will plan and uphold high-quality standards to meet compliance requirements, along with any other duties assigned.

⛳️ Requirements

• A Bachelor's degree, ideally in the life sciences, clinical or other relevant technical fields.

• A minimum of 5 years of clinical study experience (pharmaceutical, medical device, IVD, biotechnology, or CRO), demonstrating the ability to lead cross-functional clinical teams in the planning, execution, oversight, and reporting of complex, global, multicenter studies from initiation through closeout.

• At least 5 years of project management experience, preferably utilizing MS Project.

• Strong knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulatory requirements.

• Hands-on experience managing the Trial Master File (TMF), ensuring its accuracy, completeness, timeliness, and ongoing inspection readiness in compliance with ICH-GCP and regulatory standards.

• Proven capability to influence cross-functional teams without formal authority and collaborate with others to achieve project goals, timelines, and deliverables.

• 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.

• Successful project management skills with meticulous attention to detail.

• Strong client and vendor relationship management abilities.

• Capability to work effectively and independently with multi-level teams, manage multiple projects, and thrive in a fast-paced, evolving environment.

• Exceptional written and verbal communication skills, alongside strong interpersonal, negotiation, and relationship-management capabilities to effectively engage a diverse 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 skills, with a proven track record of delivering innovative solutions.

• Strong leadership abilities, with the capacity to inspire teams and drive meaningful change throughout the organization.

• Proven capability to establish robust relationships and communicate effectively across all organizational levels and with clients, promoting cross-functional collaboration, proactively addressing issues, and leading joint initiatives to ensure timely resolution and project success aligned with strategic objectives.

• Proficient in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level Excel skills (Pivot Tables, VLOOKUP).

• Proven ability to work efficiently and collaboratively in a remote environment.

• Willingness to travel approximately 20%, with a preference for candidates residing near a major airport to facilitate travel.

🏝️ 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