We are the people who give possibilities purpose

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.

Job Description

Job Responsibilities: (Primary Duties, Roles, and/or Authorities) 

Under direct manager supervision, the Associate Clinical Project Manager will: 

• Manage  the quality and compliance of assigned clinical project(s) ensuring that they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations. 

• Plan and strategize with other business unit cross functional team members (R&D, Marketing, Quality, and other business partners) to define, implement and execute clinical strategies in support of business objectives.  

• Demonstrate a comprehensive understanding of the therapeutic areas and competitive landscapes for assigned clinical project(s). 

• Oversee the planning and execution of assigned clinical projects to ensure that deliverables are completed on time and within budget. Develop and manage metric reporting tools as needed to track project timelines and deliverables. Provide regular and ad hoc reporting of metrics to Clinical Affairs leadership. 

• Manage activities related to clinical strategy and study design, global applications, submissions, and product launches for assigned clinical project(s) as the clinical subject matter expert. 

• Develop Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), Investigator’s Brochure’s (IBs), Clinical Study Management Plans, Study Process Risk Assessments, Regulatory Management Plans, Case Report Forms (CRFs), Clinical Product Management Plans, Clinical Investigation Reports (CIRs) and other essential clinical study documents. 

• Review and provide input on the development of other essential clinical study documents related to clinical data management, clinical statistics, site management & monitoring, clinical safety management, clinical product management and clinical supplier management. 

• Develop and manage clinical study budgets and monthly financial reviews, including invoice review/approval and accruals for assigned clinical project(s). 

• Manage compliance for required reporting, including but not limited to IDE annual reports, clinicaltrials.gov, and overseas notified bodies/competent authorities. 

• Perform study and/or site-level audits of the Trial Master File (TMF) to ensure that study files are current, accurate, complete and audit-ready. 

• Oversee study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate and complete. 

• Interact with and/or oversee interactions with investigational sites, vendors, key opinion leaders (KOLs) and consultants. 

• Manage external contractors/suppliers for assigned clinical project(s) to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work. 

• Coach and ensure successful and effective relationships between study teams and investigational site personnel.