• Primary representative for eClinical Solutions and sponsor data management interaction • Responsible for monitoring and ensuring adherence to study timelines and deliverables • Accountable for the overall quality of data management activities and deliverables at the study or program level • Ensure efficiency and consistency for data management tasks across programs • Communicate with global study teams • Participate in client study kickoff and closeout/lessons learned meetings • Create materials for and present at Investigator Meetings • Develop content and deliver Sponsor CRA and/or site training • Delegate tasks, support and provide guidance to study data management team • Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text • Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications • Participate in Internal System Testing (IST) on the database/user roles/edit check specifications • Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting • Utilization of centralized data management platform including graphical patient profiles and operational analytics • Compile the sponsor UAT package • Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications • Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools • Oversee and/or perform data review for overall consistency and accuracy • Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database • Oversee and/or perform query processing/resolution • Provide ongoing data management reports and metrics • Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study • Define and develop specifications for database, programming and/or edit check changes as needed throughout the study • Track data management issues and ensure follow up to resolution • Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan • Maintain data management study documentation • Perform steps pertaining to database freeze/lock and coordinate all related activities • Ongoing evaluation of process and participate in process improvement • Assist in the creation and review of SOPs, WIs, and training materials • Mentor junior level staff and peers on all associated tasks within a study • Participate in proposal defenses • Perform other duties as requested by management