Senior Clinical Data Management

Responsibilities : Responsible for ensuring the completeness, quality and integrity of the Clinical Trial data.Ensure data quality and consistency according to applicable regulatory requirements, standard operating procedures (SOPs), processes and data standards.Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP / WI (work instructions) of CR Medicon and / or Sponsor.Ensure acknowledge, follow and to be consistent with CR Medicon policies and procedures.Act as Lead Data Manager for multiple ongoing clinical studies.Ability to train junior Clinical Data Managers and assign tasks as required.Ability to create, maintain DM Timelines.Responsible for leading team activities with the sponsor.Responsible for creating and maintaining the Global Library.Responsible for maintaining eTMF and TMF (where applicable).Hands-on data management responsibilities but not limited to : CRF collections, maintenance and tracking.User acceptance testing (UAT) for database.Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and manual review (review of data listings to verify quality and completeness of data).Create the relevant documentations / files, e.g., Case Report Forms, Data Management Plan, Edit Check Specification, Data Review Plan, UAT Plan, Data Transfer Specification, and CRF Completion Guidelines, etc.Run ancillary reports as necessary.Experience with database setup and database lock activities.Participate internal / external functional meetings as required.Peer Review Study documents as required.Serve as client contact for project meetings and DM status updates.Interact and collaborate with other project and cross-functional team members including clinical, programming, statistics, database manager, medical coder, etc.Train end users on data collection tools.#J-18808-Ljbffr