Job DescriptionResponsibilities- 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.
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.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
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$135,500.00 - $216,800.00 USD Annual
