Rochester Regional Health

Project Manager

• Liaise with ACM Global Central Laboratory clients, representing the laboratory aspects of conducting the clinical trial.
• After training, manage from 10 to 25 protocols, with contract value over $3,000,000 and >120 PM billable hours/month.
• Review clinical protocols and assist with protocol set-up functions as required.
• Develops Global Laboratory Specification Document, Investigator Manual, and protocol-specific Global Work Practice Instructions.
• Participate in quality audits and inspections per regulatory agencies.
• Evaluate and communicate monthly project metrics, including budget review.
• Conduct investigator training sessions by telephone or at investigator meetings, which involves overnight travel, frequently on weekend days.
• Travel to client events and ACM international locations as needed, requiring overnight travel.
• Assume responsibility for study conduct and on-call duties; ensure client’s goals and timelines.
• Maintain regulatory required study documentation and comply with standard procedures for collecting, maintaining and archiving materials.
• Develops protocol specific procedures as needed; knowledge of FDA, NYSDOH, GCP, ICH.

Clinical Trials Project Manager

System Administrator

• Serve as a resource promoting the development of understanding of the key elements related to electronic Quality Management Systems & regulatory compliance requirements including training opportunities to all staff at an organizational wide level
• Manage the promotion and assess the compliance with regulations, guidelines, policies and Standard Operating Procedures within the organization as it relates to the eQMS
• Provide support and key input to development groups for consultation & interpretation of regulations, guidelines, corporate standards & policies
• Provide training support of electronic document control system related updates or features to global ACM users.
• Work independently or with small teams to manage routine eQMS activities.
• Serve as subject matter expert of eQMS
• Identify and lead (as assigned) process improvements and initiatives to improve efficiency and effectiveness of eQMS
• Monitor, track and trend performance of processes within eQMS
• Recognize opportunities for improvements related to project objectives and apply sound judgement when addressing the issues.
• Independently generates solutions based on analytical skills and business knowledge.
• Support and is accountable for projects/programs that involve multi-functional teams.
• Provide systematic troubleshooting of failed processes or system software and/or technical issues reported by users; be able to quickly diagnose a problem and determine how best it can be fixed in the shortest amount of time with minimal disruption to users.
• Work with Business Owners to determine and recommend approach when eQMS system requires a software upgrade
• Collaborate with Business Owners to ensure upgrade programs/applications will match current hardware/software devices and meet business needs.
• Coordinate beta testing and system upgrades with Business Owners and EQMS.
• Evaluate system requirements (eQMS or computer needs) to determine potential enhancements or improvements to applications.
• Make provisions for planned IT maintenance outages; notify user community of system downtime; and provide coverage to IT maintenance team for eQMS system verification to allow for a system restart.
• Detailed conceptual knowledge/understanding of eQMS system operations and the planning for and responding to service outages and IT maintenance work.
• Evaluate and implement workflow and system changes per requests from Business Owners
• Manage system user profiles, permissions and roles in accordance with company policies
• Utilize the change control system to support quality, consistency, and to protect the integrity of controlled documents, and perform periodic assessments of user access as required by standard operating procedures and regulatory standards and guidelines.
• Perform other duties as assigned

Clinical Trials Project Manager

eQMS System Administrator