Job Description Clinical Trial Manager
Designs, implements and monitors clinical studies of compounds designated for clinical development. Develops protocols and case report forms, which will provide adequate efficacy and safety information for Phases 1 to 3 of clinical trials. Interacts with data management personnel to plan data entry and analysis; recruits/screens/selects competent investigators; organizes investigators' meetings; assures that Good Clinical Practices (GCPs) are followed; assures timely completion of studies; monitors data for safety and efficacy trends by reviewing clinical data; and writes clinical reports upon completion or termination of studies (in cooperation with statistical staff). Reviews requests for results of Investigational New Drugs (IND) studies, and provides input for pharmacokinetics and pre-clinical studies.
Prepares clinical portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios. Plans clinical programs and develops a timetable, budget and resource analysis for clinical programs and personnel administration. Establishes and maintains relationships with alliance partners, external companies, investigators and opinion leaders to optimize performance on clinical trial activities. Prepares manuscripts for technical journals and makes presentations at scientific meetings.
Medical Directors require a MD/PhD in a relevant scientific discipline and a minimum of 5-8 years' experience in clinical research. Associate Medical Directors require a MD/PhD and 0-3 years' clinical research experience. Pharmaceutical experience is desirable.
The Physician's Guide to Clinical Research Opportunities: How to Create a Rewarding Business and Professional Relationship Between Your Medical Practice and the Pharmaceutical Industry
Book (Practice Management Information)
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
How clinical trial managers can improve organizational efficiency without affecting quality
Steps required to make an environment (processes, organizational structure, and IT systems) that lets the enhanced operations. Clinical trials are complex and expensive, and are made complex and expensive by the processes and technologies which a clinical team has to follow.