Clinical Project Manager:
Manages projects to achieve goals within budget, on schedule, and in compliance with the Food and Drug Administration, International Conference on Harmonization, World Health Organization's Good Clinical Practices, and other applicable regulations. Designs, communicates, and implements clinical development plans and... [+] More
Clinical Project Manager:
Manages projects to achieve goals within budget, on schedule, and in compliance with the Food and Drug Administration, International Conference on Harmonization, World Health Organization's Good Clinical Practices, and other applicable regulations. Designs, communicates, and implements clinical development plans and timelines for clinical research projects. Coordinates activities of associates, CRO's, and investigators to ensure compliance with protocol, overall clinical objectives, and applicable regulations.
Assures integrity of clinical data with respect to accuracy, accountability, and documentation through review of case report forms, source documents, and medical records. Gathers metrics from all functional areas to identify and manage milestones and risks to project. Develops a risk management and mitigation plan and holds each functional group, within the project team, accountable for managing and executing to that plan. Develops and makes presentations that could lead to expanded business opportunities. Participates in proposal efforts and sales calls to enhance opportunities for future business deals with clients. Represents the company at investigator meetings. Serves as a clinical resource to Sales, Product Development, and Marketing Departments. Presents clinical information at various meetings and professional education seminars. Prepares, reviews, and revises necessary clinical documents, such as protocols, guideline informed consent forms, investigator brochures, study operations manuals, study and safety reports, and clinical sections of annual reports. Maintains confidentiality of study protocols and subjects. Ensures security of all radiographic images and study and regulatory documents. Evaluates and participates in selection of consultants, CRO's, and other vendors, and studies sites to perform clinical research activities. Identifies cost and schedule variances, and develops and implements corrective actions for negative variances. Selects and hires employees, and trains and evaluates them to enhance their performance, development, and work product. May negotiate contracts with investigational sites and laboratories for content and pricing, ensuring that all regulations and legal requirements are met. May travel to field sites to supervise and coordinate clinical studies. (Source: eDOT Job Description) [-] Less
Cost of Living Data
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