As a member of the clinical team, manages clinical studies for the development of OPDC drugs. Interacts with expert physicians, investigators, vendor/CRO personnel, and functional area staff to ensure that the clinical program is run according to ICH, FDA, and OPDC guidelines. Ensures compliance with FDA and international regulations, GCPs,and SOPs. Oversees Lead CRA (protocol leads) and provides oversight to CRAs in their day-to-day conduct of the clinical trials. Leads the organization, preparation and presentation of program level information for internal and external meetings. Drafts protocols and portions of consolidated documents for regulatory submissions. Ensures smooth communication and interaction on project-related activities. Reviews and analyzes program level data on an ongoing basis. The Director or Associate Director, Clinical Development may identify other services as appropriate.
Acts as the operational lead for all protocols on assigned program(s), including contributing to the development
and implementation of project strategy.
Plans, organizes, communicates, and implements domestic and global trials for a compound.
Oversees the CRAs in their conduct of the day-to-day operations of assigned protocol(s), including:
Drafts protocols, operations manuals, CRFs, informed consent forms, and other documentation required for
regulatory submissions.
Manages vendor (e.g., CRO, central lab, sites, SMO); creates and maintains study-related tracking
(enrollment, monitoring, regulatory documents, etc.); designs recruitment strategy; reviews clinical site
monitoring reports; manages data query resolution; reviews tables and listings; and prepares and reviews
final study reports.
Acts as a resource to the CRA staff to identify problems and propose solutions to maintain projects within
designated timelines and budgets.
Leads the organization, preparation, presentation, issue identification, and follow-up for all portions of investigator
meetings.
Acts as the Clinical Study Report Owner and provides appropriate sections for Clinical Study Reports. Reviews
draft documents.
Co-ordinates training programs for CRAs and investigator meetings.
Ensures smooth communication and interaction on project-related activities.
Provides ongoing analysis, interpretation, and presentation of data.
JOB REQUIREMENTS
Minimum Requirements:
Bachelor’s degree in Science or Statistics.
Minimum of 5 years of experience in managing clinical trials/programs, study management and clinical research monitoring.
Working knowledge of the clinical and scientific basis for assigned clinical programs, and the ability to use that knowledge in operational management.
Demonstrates a strong scientific and analytical knowledge base of the compound(s) under development.
Knowledge of and ability to implement outsourcing and CRO management best practices.
Solid understanding of global regulatory requirements.
Understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
Demonstrated skill in designing and managing global clinical trials.
Able to work across multiple therapeutic areas and at different stages of clinical development.
Strong oral and written communication skills.
Excellent organizational and planning skills.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Strong problem solving and analytical skills.
Knows how/when to apply organizational policy or procedures to a variety of situations
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