Global Study Data Leader

Role Summary

Global Study Data Leader is responsible for leading the end-to-end data management activities and associated quality deliverables for clinical trials including study set-up, conduct, and close-out, complying with GCP and applicable regulatory guidance. Provide comprehensive data management expertise and support to team members. Coordinate cross functional teams globally to ensure the flawless conduct of a clinical trial. Ensure activities are completed according to agreed standards and timelines and serves as the Data Management representative in the study team.

Responsibilities

• Contributes to the implementation of department initiatives and objectives as well as cross-functional working groups. Implements and oversees processes and coordinates activities in conjunction with the internal team and Clinical Data Delivery Leader continually evaluates processes and applications for improvements.
• Oversee vendor activities to identify risks and ensure that activities are completed according to the SOW, regulations, and with expected quality. Implement quality control strategies and remediations as necessary.
• Ensure that all external data loading and integration activities (Incl. eCOA, IRT, central labs) are well established and that data is loaded as per study timelines (including transfer specifications and reconciliations).
• Ensure data quality by conducting and/or overseeing data management activities including validation, data review, and safety data reconciliation.
• Ensures an efficient implementation and follow-up of DM activities for outsourced trials.
• Develop and drive the retro planning for important deliverables such as Interim Analysis, DMC, partial, and final database locks. Ensure clear and prompt updates and escalations to study teams and management.
• Ensure Database lock readiness by leading the team through the DM lock recommendations and rational, including implementation of Data Point Lock Strategy.
• Drive inspection readiness by ensuring ongoing TMF completion for all DM related documents (including documents coming from third parties if applicable).

Qualifications

• 5+ years of experience in Clinical Data Management in the pharmaceutical industry (or equivalent) is required. 2+ years of project management experience in Data Management is required.
• Clinical Data Management System experience (CDMS) and understanding of database/programming concepts.
• Understanding of industry standards, terminologies, (e.g., CDISC SDTM, MedDRA, etc.) current regulatory guidelines, and GCP practices regarding Data Management.

Education

• Bachelor‚Äôs degree or above, preferably in a life science or health related field or/and 8-10 years of Clinical Data Management in the pharmaceutical industry or equivalent can substitute a formal degree.

Skills

• Strong Data Management expertise; understanding of Data Management scope and objectives.
• Solid knowledge of the clinical trial development process and understanding of regulatory guidelines, GCP, industry standards, and practices regarding Data Management.
• Solid Clinical Data Management System experience (CDMS & EDC) and understanding of database development/programming concepts.
• Strong collaboration and interpersonal skills; ability to manage activities with study teams and other DM functions; effective negotiation and communication, risk identification, and escalation.
• Project management skills; ability to think critically and solve multidimensional problems with timely solutions.
• Mentor and Coach: ability to mentor and coach new Data Managers on operational aspects of a trial.
• Experience in data management outsourcing and vendor management; ability to present data management topics at CSO level or at a relevant conference; responsible for data quality delivered by team members at study level.