Job Description Summary

Job Description

We are the makers of possible 

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. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Clinical Project Manager

Working within the Medical Affairs (Clinical Development) organization, the Clinical Project Manager 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 Clinical Development or Contract Research Organizations (CRO). The Clinical Project Manager may also serve as mentor to other Clinical Project Managers and Coordinators. 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, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters

• 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 test plans, protocols, clinical summary 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 CRO’s.

• Intermediate knowledge, of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, 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 GCA 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 timely delivery of the project including critical issues if needed

• Plans and maintains high quality standards in order to meet compliance requirements.

• Ability to travel approximately 30% of the time, US and Internationally.

•  All other duties as assigned

Requirements:

• Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas.  Advanced degree desirable (e.g., MS, MBA, PhD, MPH, PharmD, MD).  

• Minimum of 5 years project management experience preferred

• PMP certification highly desirable.

• Minimum 5 years of related clinical study experience, (e.g., pharmaceutical, medical device, IVD, biotechnology, CRO) including the solid ability t