Data Management Quality Lead

2 weeks ago

Bengaluru, Karnataka, India ScaleneWorks Full time
About the Role

We are seeking an experienced Data Management Quality Lead to join our team at ScaleneWorks. This is a key position responsible for ensuring the quality and delivery of end-to-end DS&M study related activities.

Key Responsibilities
  • Accountable for the electronic Case Report Form and Diary Cards & other clinical outcome assessments.
  • Defines and executes the Data Management Strategy including data ingestion, cleaning & reconciliation.
  • Ensures interim and final cleaned database lock.
  • Archives all DM documents in the eTMF.
  • Provisions clinical data to the study site.
Study Management
  • Accountable for one or several complex studies.
  • 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).
Day-to-Day Operations
  • Leads the day-to-day DS&M operational study related activities.
  • Acts as a member of the study core team.
  • Serves as the single point of contact for all the DM study related activities & matters.
Study Oversight
  • Conducts sponsor oversight of the end-to-end FSP/FSO study related activities.
  • Ensures training on the protocol to the FSP resources working on the study.
Reporting and Communication
  • Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register.
  • Reports, status updates, feedback and advice to key study stakeholders on study progress.
Budgeting and Forecasting
  • Overses and provides input to the development of budgets forecasts for FSP and FSO contracts.
Timelines and Deliverables
  • Creats or reviews study level timelines for DM deliverables.
  • Ensures teams adhere to these timelines.
Clinical Data Standards
  • Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity.
Issue Resolution
  • Acts as the first point of escalation for all DM study issues.
  • Understands, mediates and solves issues related to DM study deliverables.
Compliance
  • Ensures DM study deliverables are in compliance with global pharma company SOPs and regulatory guidelines.
Professional Relationships
  • Develops and maintains excellent professional relationships with study team and other key stakeholders.
Mentorship and Expertise
  • 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.

$120,000 - $150,000 per year, depending on experience and qualifications.

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