Clinilabs

Project Manager

• Serve as Corelab Project Manager on studies, and/or site certification, device management, scoring reliability.
• Provide leadership and guidance to Data Coordinators.
• Create training & delegation of responsibilities documents for support staff.
• Provide support and act as the point person to the Sponsor, CROs, vendors, clinical sites, and scorers for questions regarding core lab data management.
• Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members.
• Manage and track project timelines and quality issues.
• Develop training and reference materials and/or presentations as needed.
• Develop study-specific SOPs.
• Coordinate and manage training, documentation, and communication with stakeholders.
• Maintain and manage budget/finance tracker, and change order management.
• Evaluate and analyze data submitted by various parties to ensure it meets the criteria set by the study protocol.
• Monitor and update study database to ensure that all data is being processed in a timely manner.
• Perform data entry and data QC.
• Perform query generation and tracking and oversee query resolution.
• Create a study-specific electronic regulatory binder and screening binders, where applicable.
• File and store documents according to protocol.
• Track study progress and issue periodic status reports as needed.
• Manage and track study device database.
• Assist in the creation and documentation of new or revised data management, IT and quality assurance procedures.
• Communicate with all operational departments regarding project status/issues.