Hybrid
Full Time
ESSENTIAL DUTIES AND RESPONSIBILITIES: This position requires a minimum of 50% of the employees time be spent performing operational tasks outlined below: Investigates and issues queries to sites/sponsors to verify/obtain demographic and visit information on ECGs, Holters and Flashcards/Transmittal Forms. Investigates and enters resolutions received from Data Clarification Requests. Maintains accurate and complete Data Coordination files for all resolutions received, including filing signed DCFs and Data Revision Request Forms in protocol and/or investigator folders. Investigates and performs Self Evident Corrections as outlined in the SEC Guidelines in the Data Coordination System Independent SWI or documented in the PRS. Performs revisions received on Data Revision Request Forms for EXPeRT Attends Project Assurance meetings and outlines feedback to Data Coordination via email. Maintains minimum departmental metrics. Assists with the Data Entry, Scanning and Barcoding procedures for the Data Acquisition team. OTHER DUTIES AND RESPONSIBILITIES: The remaining 50% of the employees time will be allocated as follows: Monitors daily workflow of the Data Coordination and Data Acquisition Team. Maintains an accurate assessment of existing and projected workload and expected timelines. Ensures equal distribution of work to all team members. Adjusts team member assignments as required to maintain operational efficiencies. Training: Trains new staff in the daily operations of the Data Coordination Department. Assists in performing the 6 month evaluations for all new Data Coordination members. Provides feedback through routine one-on-one meetings and writes performance reviews for all Data Coordinators. Maintains daily communication between shifts. Communicates any issue that will need follow-up on another shift Communicates deadlines: Keeps all shifts adequately informed about procedure changes and workload demands. Assists in the development and maintenance of department SOPs and Working Practices. Prepares client activity metrics (paper ECGs received and processed, queries received and resolved, etc.) and any specific information regarding problematic accounts for presentation and discussion at Client Meetings. Attends, or sends a delegate to, all planning meetings. Record and distribute information relative to Data Coordination activities to the team. Present Data Coordination issues. Mentors Data Coordinators on the nuances of query resolution and issuance, including wording queries to sites/sponsor, researching issues through EXPeRT systems and the Data Cleaning Application. Oversee the daily functions of the query department to ensure that metric goals are being achieved. Track and monitor employee productivity and quality metrics. Coach DCs and DAA to achieve and exceed targets. Ensure all procedures and processes outlined in global SOPs and SWIs are adhered to. Provide training on updated SOP/SWI and system enhancements as appropriate. Ensure accurate and timely collection of demographic and visit data. Maintain workflow to meet turnaround time requirements by monitoring system queues and reports as necessary. Conduct monthly individual and team meetings to review metrics, upcoming or outstanding work and both individual and departmental goals and objectives. Report to management the conduct, efficiencies and metrics for staff performance. QUALIFICATIONS AND SKILLS NEEDED: (Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.) Education : BS or BA degree in life sciences or related field or 7-8 years departmental or related experience. Experience : Strong investigational and documentation skills. Positive mentor to new and existing team members with ability to motivate co-workers. Detail oriented, with ability to prioritize. Ability to adapt to shifting demands. Excellent organizational, communication and computer skills. Good presentation skills.
Clario
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