Clinical Trial Manager

Clinical Trial Manager

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 document 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 negotiations 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 World Wide 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. Managed and executed Scientific Input Engagements and Global Therapeutic Expert Forums (Investigator Meetings) for the Therapy area assigned in compliance with all US and International government regulations. Supported the Global Scientific Affairs Team for the therapy area assigned and activities surrounding scientific leadership strategy which drove post-marketing and clinical research initiatives. Managed Investigator Initiated Studies Program from study initiation to study completion. Managed Global Scientific Affairs budget and reported financial status monthly. Telecommuting is permitted. Requires a Bachelor's degree in in Business Administration, Clinical Studies, Science, or Health-Related field (or its equivalent) plus 5 years of experience Requires 4 years of experience with : Supporting the oversight, planning and management of a Global clinical study in alignment with the global study plans and specific clinical study deliverables. Provides input to the development or updating of the Global study specific resources and plans and deliverables. Supporting risk assessment and identifying risk mitigation strategies related to assessment of site feasibility and selection, recruitment strategies, patient enrollment and retention, and data analysis. Supporting the oversight and management of required third party vendors. Supporting data quality by participating in regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites and escalates data flow and data quality issues to the study management team. Contributing to clinical project audit and inspection readiness throughout the study lifecycle to ensure patient safety and data quality parameters are met. Excellent communication and interpersonal skills with ability to build strong working relationships with internal and external stakeholders and provide excellent customer service to the client. Proactive and able to prioritize responsibilities with high attention to details to meet deadlines and deliver on specific study activities. Experience in clinical trial operations including having a strong working knowledge and ability to implement ICH / GCP and regulatory guidelines / directives on a practical level. Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS / IWRS, EDC, eTMF. Supporting investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB) / Independent Ethics Committee (IEC) requirements. Preparation of regulatory submissions to applicable Regulatory Agency. Telecommuting is permitted 40 hours / week. Must also have authority to work permanently in the U.S.