Project Manager

The project manager, PM, is a paramedical who assists the clinical research physician during the conduct of investigative clinical trials.

Some of the responsibilities of a PM include:

• protocol development (preparation of plan to conduct an investigative clinical trial)
• initiation of clinical trials (identifying qualified investigators, qualifying trial sites, submitting appropriate documents to regulatory bodies, coordinating trial with sponsors, etc..)
• monitoring and ordering of clinical trial materials (human subject binders, regulatory binders, lab supplies, etc.)
• administration of clinical trials (assisting investigators / sites in regulatory document submission, etc.)
• preparation and facilitation of clinical trial trainings (investigator start-up meetings, teleconferences, etc.)
• monitoring of clinical trials (reviewing inclusion / exclusion criteria for human subjects, qualifying study entry for human subjects, conducting site initiation / interim / and close-out visits, etc.)
• data validation transcribed by site to case report forms (verifying accuracy, matching source documents to case report forms, etc. )
• monitoring site quality (coordinating procedures and processes of a protocol in a timely, efficient manner).
• preparation and submission of monitoring trip reports, as well as expense reports and site reports, etc.)
• development and maintenance of site relationship during the conduct of the clinical trial
• monitoring of safety and efficacy data (preparing appropriate reports for regulatory and site submission, etc.)
• project management of clinical trials
• coaching and training of new employees
• conducting in-services to sites and employees
• preparation of case report forms and source document worksheets
• budget negotiation and grant preparation for investigators
• organization and preparation of new drug applications
• initiation and preparation of letter of confidentiality and letter of agreement to / from investigator

As you can see, a project manager is a very important and active participant on the study team.

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