The Study Data Manager (SDM) is responsible for leading the end-to-end data management activities and associated quality deliverables for clinical trials including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensure activities are completed according to agreed standards and timelines. Serve as the DM representative in the study team. Provide comprehensive data management expertise and support to team members. Coordinate cross functional teams globally to ensure the flawless conduct of a clinical trial. 

This includes: 

• Being accountable for the quality and timely of data management deliverables for the assigned studies including delivery of accurate and reliable clinical study data to ensure the reliability of the study results. 

• Representing Clinical Data Management in the Core Trial Team (CTT). Liaises directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all data management activities for assigned studies, discuss timelines, and provide study data management updates. Suggesting solutions for data management issues that arise during the conduct of a study and monitor until resolution. 

• Planning of all data management activities considering the core study milestones and ensuring that DM activities are conducted as planned. 

• Leading DM activities with internal DM delivery team (Database Developers, Data Management Programmers, Central Monitors, etc.) assigned on the study and mentoring new SDMs. 

• 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/Visualizations as per company standards and protocol requirements. 

• Assuring that data management standards are followed. 

• Managing study document archiving in eTMF according to eTMF guidance.  

• Participating in Investigator Meetings and other outside meetings if required.  

• When necessary contributing to the delivery of data management activities. 

• Maintaining 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 approaches. 

• Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of a study. 

• Coordinating, in collaboration with vendor(s) and internal data integration experts, all external data activities: loading, integration activities and reconciliation activities, including Central Labs, eCOA, IRT, 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.  

• Ensuring vendor oversight on data management activities at the study level while maintaining a good working relationship with the vendor(s). 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 as necessary. Ensures all vendor contract related documents are processed on-time. 

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