BD (Becton, Dickinson and Company) Clinical Project Manager I in Vernon Hills, Illinois
Job Description Summary
Working within Corporate Clinical Development (CCD), the Clinical Project Manager I executes studies conducted by CCD. Clinical studies may range from simulated use studies (employing a clinician to use the device in a simulated environment) to complex studies in human subjects and/or specimens that may include devices, in vitro diagnostics (IVDs), drugs, or drug/device combinations. The CCD supports all BD business units.
Clinical Project Manager I serves as a study/project manager for studies of low to moderate complexity from protocol development through study conduct and study closeout in compliance with Good Clinical Practices, and all National and Local Regulations.
Develops clinical research protocols
Interfaces with clinical data management and statistics in developing case report forms, managing data cleanup, and analyzing study data
Develops project budget/schedule in collaboration with Core Team and/or Program Management
Oversees site selection and training
Trains and oversees monitoring teams (CRAs) and the timeliness and quality of their work
Oversees study vendors (reference labs, CRO, other potential vendors)
Obtains, reviews and approves study documents
Maintains trial master file and all relevant trial documentation
Performs study execution and status reporting activities
Prepares final clinical study report and oversee study closeout activities
Leads study teams for studies of moderate to high complexity
Contributes to department/function continuous improvement activities/initiatives
Bachelor degree required.
Minimum of 2 years’ experience in relevant areas. Preferred experience areas include the Life Sciences or other relevant technical areas, such as Clinical trials, Regulatory Affairs, or Quality.
Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, RAPS) desirable.
Project management skills required to include the use of a formal process and system for planning and tracking ongoing progress of clinical projects
Proficiency with MS Project highly desired
Knowledge and experience of Good Clinical Practice (GCP) and ICH requirements required. Knowledge of additional/local regulations a plus.
Vendor management experience required.
The Clinical Project Manager is expected to travel approximately 30% of the time, US and Internationally.