Clinical Project Manager

Job Description
The Clinical Project Manager (CPM) will function as a Study Team Leader‚ organizing and managing all operational aspects of the study from conception to submission‚ ensuring adherence to timelines. The CPM will also proactively address risk management through contingency planning. The CPM will manage critical study issues such as vendor contracting‚ budgeting‚ and drug supply. Major activities include:

Develop and coordinate the operational plans for a clinical study or multiple clinical studies within a development program.
Lead Study Teams including CRO management.
Manage the progress of project(s) and ensure adherence to intended timelines including enrollment‚ clinical supplies‚ and data delivery.
Manage planning‚ distribution and proper labeling of clinical supplies globally on a program or protocol level.
Coordinate with all relevant groups to develop clinical project timelines and maintain Gantt charts.
Disseminate clinical project communications to all functional groups and vendors as appropriate.
Identify issues that may impact the overall project plan and initiate contingency plans as appropriate.
Develop protocol level clinical study budgets.
Review site recruitment‚ initiation and patient enrollment progress and review and act on trending reports. Develop and maintain relationships with sites (PI‚ coordinators‚ etc.).
Develop‚ with the Project Physician‚ all operational contingency plans and trigger points for these contingencies.
Collaborate with the Project Physician and Clinical Director on SAE reconciliation.

Education

Bachelor of Science in Health Sciences‚ Nursing‚ or related field

Skills

6–8 years experience in clinical research (oncology experience preferred)
Project management experience
Participation in multiple Study Teams
Protocol execution experience (i.e. site selection through database lock)
Site monitoring experience strongly preferred