JOB SUMMARY

The Corelab Project Manager manages core lab data (e.g. PSG, MWT, MSLT, PVT, EEG, ECG, etc.) relating to various studies.                    

RESPONSIBILITIES

• 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
• Willingness to work a flexible schedule, outside of normal business hours, including on-call rotations
• Follow and ensure compliance with current Good Clinical Practices 
• Adhere to corporate policies and procedures
• Other duties as assigned

TRAVELING

Travel as needed.

• The position requires at least 5 years of experience in a Data Coordinator role and/or comparable roles. A bachelor’s degree is strongly preferred.  
• Strong computer (Microsoft Windows and Office Applications) and communication (oral and written) skills are required.   
• Must have detailed documentation and project management skills.