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JU15105 - CLINICAL PROJECT MANAGER
The ideal candidate manages clinical project team members to appropriate and timely completion of projects; oversees project timeline development and maintenance. Internally interfaces with data management and biostatistics, field clinical monitors, medical directors, liaison with investigators and clinical site staff.
Job Responsibilities:
Participates in the design and planning of clinical research projects.
Manages projects to achieve goals within budget and on schedule.
Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
Oversees clinical monitoring from site qualification to site closure visits and assures integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents and medical records.
Maintains a high level of professional expertise through familiarity with clinical literature and participates in or leads clinical project team meetings.
Participates in process of selecting sites for clinical trials on investigational new drugs: assures patient eligibility, communicates and documents protocol violations, reviews and updates site-specific consent forms and documents site progress via standard reports.
May travel to field sites to supervise and coordinate clinical studies. Writes or assists with writing clinical development plans and other clinical documents.
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