Data Management Lead

2 weeks ago

Bengaluru, Karnataka, India ScaleneWorks Full time
Key Responsibilities:

As a Data Management Lead at ScaleneWorks, you will be accountable for the end-to-end delivery of DS&M study related activities, ensuring quality and adherence to plan. This includes:

  • Electronic Case Report Form and Diary Cards & other clinical outcome assessments
  • Defining and executing the Data Management Strategy, including data ingestion, cleaning & reconciliation
  • Interim and final cleaned database lock
  • Archival of all DM documents in the eTMF
  • Archival of the study database and provision of clinical data to the study site

You will be responsible for managing the delivery of complex studies, with the ability to manage different therapeutic areas, complex/unusual early phase settings, new/unusual indications, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies.

For in-house studies, you will lead day-to-day DS&M operational study related activities, act as a member of the study core team, and be the single point of contact for all DM study related activities & matters.

For studies outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO), you will conduct & document sponsor oversight of the end-to-end FSP/FSO study related activities and ensure training on the protocol to the FSP resources working on the study.

You will provide DM operational input into the study design, the protocol, study planning, study documents including the study risk register.

You will provide reports, status updates, feedback and advice to key study stakeholders on study progress.

You may oversee and provide input to the development of budgets forecasts for FSP and FSO contracts.

You will create or review study level timelines for DM deliverables and ensure teams adhere to these.

You will promote the implementation of clinical data standards to increase consistency, efficiency & productivity.

You will act as the first point of escalation for all DM study issues, understanding, mediating and solving issues related to DM study deliverables and escalating as required to DM representative at Asset level.

You will ensure DM study deliverables are in compliance with global pharma company SOPs and regulatory guidelines.

You will develop and maintain excellent professional relationships with study team and other key stakeholders.

You will act as a mentor for junior members of the DS&M team.

You will act as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections.

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