Description :
Overview :
Responsible for the development and management of complex Phase I-IV clinical research studies according to applicable federal regulations and guidance, ICH, GCP and Medicis SOP's. Relies on experience and judgment to plan and accomplish goals. Guides work procedures and standards to improve efficiency and effectiveness of the department. Requires the ability to apply the Federal regulations and guidelines governing clinical trials to the management of ongoing studies and the development of new pharmaceutical and device clinical trials. Must have an adequate understanding of the rationale and genesis of Medicis SOP's to be able to appropriately interpret and apply them to clinical trial settings. Requires the effective management of multiple sites and vendors while maintaining a global view of the clinical development process, ensuring consistency of sites' understanding and application of the protocol requirements. Must respond to problems effectively while remaining attentive to the protocol requirements, regulations, sponsor goals, and investigative site clinical practices. Responsible for the management of Clinical Research Associates, including study and site monitoring assignments, performance management, staff development and training.
Responsibilities :
In-house management of complex Phase I-IV clinical research studies. Requires an excellent working knowledge of the federal regulations, GCP, ICH, and Medicis SOP's regarding documentation requirements, regulatory reporting requirements, and protection of data integrity. Must be able to problem-solve efficiently and effectively from a global point of view. Includes the training and personnel management of the Clinical Research Associate staff.
Development of clinical start-up plans. Requires an excellent working knowledge of the protocol, clinical practices, and training requirements. Must anticipate issues that may arise and recommend appropriate actions to be taken.
Selection and qualification of vendors and investigational sites. Requires an excellent working knowledge of the federal regulations, GCP, ICH, and Medicis SOP's regarding clinical trial site and vendor qualifications.
Development of study documents, forms and manuals required for clinical trial management in the manner specified by Medicis Clinical Research SOP's related to study documents and in compliance with FDA regulations & ICH guidelines. Must follow a format suitable for review by an FDA investigator. Must incorporate protocol knowledge, data management requirements, and a firm understanding of the desired study end point.
Design and manage the tracking of clinical study progress. Requires knowledge of study timelines, FDA and IRB reporting requirements. Must provide regular verbal and written study status reports to the clinical team and upper management.
Qualifications :
5-7 years experience
Bachelor degree in the health sciences or related field
Minimum 2 years experience working in a health care setting required
3-5 years experience with clinical research and/or clinical study programs required
Dermatology research experience preferred
PC proficiency to include MS Word, Excel, Powerpoint, and email systems (MS Outlook)
Extensive experience with the IND to NDA application process
Demonstrated knowledge of GCP and pharmaceutical record management
AA/EEO Employer