3 Data Coordinator Jobs

Work with team members to ensure both company and department SOPs and Working Practices are being followed. Ensure protocol compliance according to documented protocol requirements. Conduct initial training of all new team members. Maintain production and quality metrics for team members. Direct the daily workflow of the team by monitoring queues and work assignments to ensure all team tasks are completed daily. ESSENTIAL DUTIES AND RESPONSIBILITIES: This position requires a minimum of 50% of the employee s 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 employee s 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 3-5 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.

Premier Research is looking for a Data Coordinator - DM to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What youll be doing: Assists in testing of databases (DBs) and maintenance of study data, including the processing of discrepancies and queries. Reviews Case Report Forms (CRFs), data listings, and DBs to ensure that all captured data follow the rules outlined by the protocol, CRF Completion Guidelines (CCGs) and departmental plans. Collaborates cross-functionally with colleagues to ensure the integrity of clinical databases. Prepares documentation, such as CCGs, Data Management Plan (DMP), Data Report Assists in developing standard test data for testing screens and listings and provides feedback on the results of the testing Performs user acceptance testing on studies, including testing of edit checks, etc. Assists in maintaining DBs and supports DB updates Performs data entry Generates reports for data review Reviews CRFs, data listings, and DBs to ensure all data captured follow protocol, CCGs, DMP, etc. Generates queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the data management (DM) process Reviews responses to queries and resolves discrepancies Performs external data and/or serious adverse event reconciliation Acts as a Lead Data Coordinator and/or Safety Reviewer on multiple studies Performs document submission to Trial Master File (TMF) Supports TMF Quality Control (QC) activities Performs database QC activities Performs QC of study reports, CRF archive files Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status What we are looking for: Bachelor s Degree or above (preferably in a Life Science) Typically requires 2 -4 years of DM mastery or related clinical research industry experience Knowledge of at least one Clinical Data Management System (CDMS) (e.g. Medidata Rave, Calyx EDC, etc.)

1- 2yr of Clinical Data Management Experience . Perform/Assist the Data Manager in managing various data management projects as per sponsor requirements and to provide efficient, quality management products. Support coordinate with other departments, sites and sponsors as and when necessary Essential Functions Perform/Assist regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor. Serve in the role of back-up to a Sr. Data Coordinator or Data Team Lead. Manage the allocated tasks with minimum oversight. Ensure that all the deliverables are of expected quality standards and meet customer expectations with support of Senior Data Manager. Interact with Data Management team leaders to report on the quality of data collection and tasks done. Attend internal study meetings and internal/ sponsor audits. Assist in tracking and managing the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended by DTL. Be compliant to trainings and eSOP reading. Communication with Data Team Lead and other team members across functions should be collaborative. Qualifications Bachelors Degree Graduate Science/Bachelor Pharmacy or equivalent Pref English Fluency Spoken and English Basic computer applications like Microsoft excel, word, Inbox etc Should have basic understanding of Drug development lifecycle and Overall Clinical research process