Key Responsibilities::

• Accountable for the end-to-end DS&M study related activities in terms of quality & delivery to plan which include:
o Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments
o Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
o Interim and final cleaned database lock
o Archival of all DM documents in the eTMF
o Archival of the study database and provision of clinical data to the study site
• Accountable for one or several complex studies, and has the ability and experience to manage the delivery of any type of study (different therapeutic areas, complex/unusual early phase setting, new/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies)
• For an in-house study, leads the day to day DS&M operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters
• For a study outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO), conducts & documents sponsor oversight of the end to end FSP/FSO study related activities and ensures training on the protocol to the FSP resources working on the study
• Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register
• Provides reports, status updates, feedback and advice to key study stakeholders on study progress.
• May oversees and provides input to the development of budgets forecasts for FSP and FSO contracts.
• Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these
• Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity
• Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level
• Ensures DM study deliverables are in compliance with global pharma company SOPs and regulatory guidelines
• Develops and maintains excellent professional relationships with study team and other key stakeholders
• Acts as a mentor for junior members of the DS&M team
• Acts as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections

406334 Study Data Manager-1

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