Associate Director, Data Management

Role Overview

• Lead data management efforts to coordinate study from start-up activities, interim data cuts to support various activities, to close out activities
• Represent data management function at cross-functional meetings
• Lead regular data review meetings in a cross-functional team environment.
• Responsible for data cleaning, query and resolutions, review of medical coding
• Oversee or responsible for external lab data reconciliation, manage and reconcile external data, authoring data transfer agreements
• Lead or oversee database lock activities and ultimate archiving of study data
• Supervise and mentor supporting data managers to ensure data management activities are conducted as expected
• Lead eCRF development and facilitate cross-functional reviews of specification
• Oversee and direct database building activities, including review of edit check specifications, lead and perform the user acceptance testing
• Monitor data collection, data cuts, coding, and cleaning by CROs through tracking of study metrics and targeted data reviews
• Review data management plans, CRF completion guidelines, external data transfer specifications and other study documentation, ensuring all data management documents are completed and to be filed in the study eTMF and are ready for regulatory inspection
• Using data visualization tools to perform data review or quality check data with cross function teams
• Review clinical study protocols and statistical analysis plans
• Participates in other activities and meetings to support Data Management/Biometrics as necessary
• Support in the SOP’s, working instruction, templates development for data management head of the Data Management

Requirements

• B.S. / B.A. in scientific discipline (minimum undergraduate degree required), with 7 years of Data Management experience and a minimum of 4 years of leading or vendor oversight experience
• Experience with medical dictionaries, including MedDRA and WHODrug
• Proficient with electronic data capture (EDC) systems like Veeva EDC, Medidata-RAVE and the development of CRF/eCRF for clinical trials and its impact in database design/development
• Proficient experience working in an outsourced data management model.
• Excellent verbal and written communication, organization and time management skills

Benefits

• Health insurance
• 401(k) matching
• Flexible work arrangements
• Professional development opportunities