Clinical Project Manager Jobs description

The primary responsibilities of a clinical project manager consist of designing and planning of clinical research projects, preparing necessary clinical documents, such as protocols, guideline informed consent forms, investigator brochures, transfer of regulatory obligations forms, study operations manuals, preparing and reviewing Statements of Work and Requests for Proposals, overseeing teams collecting essential regulatory and other study-specific documentation related to assigned projects, managing primary project management for one or more moderately to highly complex clinical research projects, developing and updating SOPs and study-specific procedures pertaining to management of clinical studies and clinical research activities, managing projects to achieve goals in compliance with the budget and time schedule.
He/she is responsible for participating in process of selecting sites for clinical trials on investigational new drugs; assuring patient eligibility, communicating and documenting protocol violations, reviewing and updating site-specific consent forms and documenting site progress via standard reports.

A bachelor\\\'s degree in Health Science is required for the position of a clinical project manager. A clinical project manager should be experienced in working with project management methodology, well conversant with FDA regulations, GCP/ICH guidelines and clinical development process and should be proficient in MS Word, Excel, PowerPoint, MS Project.

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