Clinical Data Management

Clinical Data Management is responsible for overseeing the end to end DS&M study related activities and is accountable for all DS&M study deliverables in terms of quality & delivery to plan.

Key Responsibilities:

• Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan
• 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
• Accountable for one or several complex studies, and has the ability and experience to manage the delivery of any type of 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
• 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
• 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
• Ensures DM study deliverables are in compliance with GSK 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

Basic Qualification:

• Bachelor’s degree in a scientific, clinical, computer, or related discipline
• Minimum of 4 years’ experience in data management or clinical trials within pharmaceutical, contract research organization (CRO), or academic research settings
• Practical knowledge of Good Clinical Practice and regulatory requirements for clinical data management
• Experience managing relationships and oversight with external vendors or service providers
• Strong English communication skills, both written and verbal, for effective global collaboration
• Proven ability to plan and deliver study-level activities and timelines