河源招聘

·      Assuming Lead Data Manager (L-DM) role and autonomously acting as one of study team core member; liaises directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Risk Based Monitoring, Pharmacovigilance, Quality, etc.) to lead all data management activities for assigned study, discuss timelines and provide study Data management reporting. Proposes solutions for data management issues that arise during the conduct of a study, and monitor until resolution.

·      Assuming the plannification of all data management activities, considering the overall study timelines and ensure DM activities are conducted as planned.

·      Leading and coordinating internal DM delivery team (Database Developers, Data Management Programmers and Data Management Specialists) assigned on the study; working as a mentor for new Data Managers and accountable for the quality of data management deliverables.

·      Accountable for the DM study deliverables, such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports as per company standards and protocol requirements. Assures that data management standards are followed. Manages study document archiving in eTMF according to eTMF guidance. Participates in Investigator Meetings and other outside meetings if required. Maintains knowledge of current regulations and technologies related to the data management function.

·      Defining and implementing the study data cleaning and validation strategy integrating risk based approach.

·      Involved, as Contributor or Leader, according to the defined processes, in protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of study.

·      Coordinating, in collaboration with vendor external data activities : load, integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc.

·      Participating in the implementation of department initiatives. Implements and oversees processes and coordinates activities in conjunction with the internal team and Team Leader. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new procedures.

·      Managing service providers (CROs) independently on data management activities and maintains a good working relationship with vendor. Reviews vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services. Performs assessment of vendor performance trends and service risks. Meets regularly with vendor representative to implement mitigation actions. Obtains appropriate approval for scope of work and budget update. Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-time.

微信分享