-
Talha Chaudhry replied to the topic Difference in the forum Introduction to Project Management 8 years, 2 months ago
I believe the two positions are quite similar in a lot of ways. I see the clinical pm as a subset of project managers as a whole. According to progenics pharmaceuticals, these are the primary responsibilities of a CPM:
-Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.
-Serves as primary contact and resource for LCRA, CRO and vendor personnel. Supports selection and provides oversight and management of CROs, consultants and vendors.
-Tracks and reports on the progress of assigned clinical trials including budget and timelines.
Preparation, oversight and review of study related documents.
-Works with Clinical Trial Managers, Data Management, Clinical Trial Assistant and Document Control Specialist to create and manage study related documents.
-Co-monitors with CRO’s Monitors to evaluate and ensure quality of CRO Monitoring Team. Ensures that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs.
-Organizes (or assists with organizing) and participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and CRO Training.
-Participate in the preparation, review, updating and training of SOPs.I believe the main difference that distinguishes CPM’s from other project managers is the amount of regulation that they need to be aware of and close involvement of the FDA.