Project Manager- MTCC

Project Manager- MTCC The Ohio State University Wexner Medical Center - 3.9 Columbus, OH Job Details Full-time 22 hours ago Qualifications Project team coordination Project reporting Management Clinical research PMP 5 years Filing Research Patient safety Master's degree Key Performance Indicators Quality assurance audits ICH guidelines Managing budgets in a finance role Bachelor's degree Public Health Research compliance experience within healthcare industry Data quality monitoring Health Science Research compliance clinical trial records management Project management software Regulatory submissions Bachelor's degree in public health Budget management in healthcare Research regulatory compliance Quality audits Healthcare data collection Senior level Regulatory audits Training Leadership Communication skills Project stakeholder communication Project scheduling FDA regulations Stakeholder management Full Job Description Job Description The Project Manager will oversee the planning, execution, and management of multisite clinical trials coordinated through Multisite Trial Coordinating Center. This role ensures that all participating sites adhere to protocol, regulatory requirements, and timelines, while maintaining high standards of data quality and participant safety. The Project Manager will serve as a central liaison between investigators, site staff, sponsors, regulatory bodies, and internal teams. Key Responsibilities: Project Oversight & Coordination Lead the development and implementation of project plans, timelines, and deliverables for multisite clinical trials. Coordinate communication across all participating sites and stakeholders. Monitor trial progress and proactively address risks, delays, or deviations. Regulatory & Compliance Ensure compliance with ICH-GCP, FDA regulations, and institutional policies. Oversee IRB submissions, renewals, and reporting across all sites. Maintain essential regulatory documents and trial master files. Site Management Support site selection, initiation, training, and ongoing management. Track site performance metrics and provide guidance to improve efficiency and compliance. Facilitate regular site meetings and communications. Data & Quality Management Collaborate with data management teams to ensure timely and accurate data collection. Participate in monitoring visits and audits as needed. Implement quality assurance processes to ensure protocol fidelity. Budget & Resource Management Assist in budget development and track project expenditures. Coordinate with finance and grants management teams to ensure fiscal compliance. Requirements: Bachelor's degree in health sciences, public health, or related field (Master's preferred). Minimum 5 years of experience in clinical research, with at least 2-3 years in project management of multisite trials. Strong knowledge of clinical trial regulations and guidelines (e.g., GCP, FDA, NIH). Experience with IRB processes, regulatory submissions, and site coordination. Excellent organizational, communication, and leadership skills. Proficiency in project management tools and clinical trial management systems (CTMS). Preferred Qualifications: PMP or ACRP/SoCRA certification. Experience working in an academic or NIH-funded coordinating center. Familiarity with REDCap, OnCore, or similar platforms. Regular 40 First Shift