Responsible for managing the full scope of proper study conduct including, but not limited too, protocol development to final report, regulatory filing and/or publications, coordinating cross functional efforts in the administration and progress of Phase 1 to 4 clinical trials. Additional responsibilities include trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.
The incumbent will use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. May determine methods and procedures on new assignments. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
MAJOR DUTIES OF POSITION:
• Performs job duties with minimal guidance from the Clinical Program Manager or Clinical Operations Head.
• Manage the project execution to ensure that trial timelines, costs, and quality metrics are met.
• May serves as primary contact for functional area representatives in managing protocol execution.
• Manage forecasting of clinical and non-clinical supplies.
• Establish study milestones and ensures accurate tracking and reporting of study metrics.
• Manage trial-specific collaborations with other research entities.
• Perform ongoing service provider management (e.g., CROs, IVRS, Central Labs), including negotiation of scope of work, budgets, performance management, and issue resolution.
• Ensures accuracy and timeliness of service provider and site payments.
• Provide input and manage clinical trial budgets and staffing/resourcing plans.
• May provide study-specific direction and mentoring to CRAs, COCs, and support staff as appropriate, and may provide guidance to other team members.
• Ensures trial adherence to ICH/GCP/local regulations.
• Participate in clinical operations initiatives and programs as assigned.
• Other duties as assigned.
KNOWLEDGE AND SKILL REQUIREMENTS:
• Bachelor’s Degree with a minimum of five years of clinical research and development experience. Experience in the conduct and management of vaccines and/infectious diseases clinical trials, a plus
• Current knowledge of regulations, clinical development process and therapeutic area of study plans.
• Effective communication skills to efficiently disseminate information within clinical as well as other functional areas as appropriate.
• Organized and highly developed leadership skills to build and direct the protocol execution to ensure that timeline, cost and quality metrics are met
• Experience developing clinical plans, eg for monitoring, feasibility and site selection, subject recruitment, and clinical supplies management.
• Clinical research and development knowledge and cross-functional understanding of clinical trial methodology.
• Collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners.
• Familiar with MSProject for development and update of clinical study timelines.
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook.
• Travel is required – anticipate 25%.
Apply Here: http://www.Click2apply.net/gf69bnm