Manager-Clinical Data

2COMS Consulting Pvt. Ltd.
  • Kolkata, Mumbai
  • 10-15 lakh
  • 3-8 years
  • Views
  • 04 Jan 2017

  • R&D/ Research & Development

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Accountable for execution and on-time delivery of planned DSS milestones from study conduct through close-out
Creates relevant documents and data cleaning plan for all assigned trials (e.g., Integrated Data Review Plans, Clinical Database Specifications, Data Management Plans), when executed as designed, will produce a clinical-trial database that is fit for purpose and adequate for statistical analysis
Updates the data cleaning plan as necessary to maintain study health during trial conduct for all assigned trials
Responsible for ensuring operational triggers and study-level timelines are accurate and up to date in respective operational systems, while ensuring compliance and quality
Responsible for any audit findings regarding process execution or data integrity for any assigned clinical trial
Acts as team SME for key systems and processes
Responsible for preparing for monthly Health of Study milestones, which includes report generation, data discrepancy identification and trending, data reconciliation, slide preparation, action-item resolution
Responsible for monitoring and communicating any data management back log as it relates to discrepancy management, data reconciliation, data load issues, document readiness, DB versioning readiness, audit readiness
Accountable for 24 x 7 readiness immediately prior to database versioning (i.e. lock) for assigned trials. Responsible for versioning databases in a regulatory-compliant manner, in accord with DS SOPs, process design and timelines
Responsible for study close out activities as they relate to system access (i.e., read-only), decommissioning, TMF/ eTMF readiness
Coordinates any post-lock database version changes
Contributes to Data and Statistical Sciences Study and Program level huddles
Accountable for Good Documentation Practices in every aspect of the operations
Accountable for supporting and utilizing Data Sciences policies and procedures
Reports into the Therapeutic Area Associate Director level in DS

Competencies/Skill sets for this job

Cdm Process Design Sops Data Reconciliation Data Management

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About Organisation

2COMS Consulting Pvt. Ltd.