Pharmaceutical Research Associates, Inc. seeks Clinical Trial Manager in Blue Bell, PA.
Duties:
• Assist with analysis of the content of each study application and check for completeness: budget, timelines, publication plan
• Facilitate review of final study report and submit abstract/manuscript to committee and databases
• You will be the primary point of contact to ensure the committee decisions are communicated and documented according to SOP
• Coordinate activities with the investigators and country point of contact to ensure approved studies are initiated, followed through, and completed within the time frame agreed upon according to the executed study agreement
• Ensure clinical studies have IRB/IEC approval and are registered on the CTDB
• Track and manage all documents via a global website and database for the Global Scientific Affairs team
• Facilitate, review, and negotiation of clinical and pre-clinical study designs, budgets, timelines, grant agreements
• Coordinate with the Global Operations Specialist regarding CDAs, study budgets, contracts, approval of payments to investigators/institutions, forecasting, and budgetary spending
• Liaise with Worldwide Regulatory Coordination to ensure appropriate documentation is obtained for clinical drug supply needs
• Responsible for fostering relationships with internal and external partners to encourage study teams to move forward during difficult times of transition within the company
• Manage and execute Scientific Input Engagements and Global Therapeutic Expert Forums (Investigator Meetings) for the therapy area assigned in compliance with all US and International government regulations
• Support the Global Scientific Affairs Team for the therapy area assigned and activities surrounding scientific leadership strategy which drove post-marketing and clinical research initiatives
• Manage Investigator Initiated Studies Program from study initiation to study completion
• Manage Global Scientific Affairs budget and report financial status monthly
Telecommuting is permitted.
To apply: Visit https://www.jobpostingtoday.com/application/18487/apply
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