Clinical Data Management Leader; CDML Associate Director Level

Purpose of Job

The Clinical Data Management Leader (CDML) is responsible for leading and overseeing all clinical data management activities across assigned clinical studies and programs. This role ensures the delivery of high-quality, reliable, and regulatory-compliant clinical trial data to support study reporting, regulatory submissions, and decision-making. The CDML provides strategic leadership, manages cross-functional stakeholder relationships, drives process improvements, and mentors Clinical Data Management professionals.

• Protocol development:
  Contribute to protocol synopsis, protocol and amendments from a data management perspective
• Be an active member of the clinical study team
• Trial start-up:
  • Oversee development and review of data collection tools: (e)
    CRF, data transfer agreements, PRO's, diaries...
  • Oversee development and review of data handling tools: data management plan, data validation plan, medical review listings, coding, SAE reconciliation plan, protocol deviations detection, ...
  • Ensure implementation of CDISC standards
• Trial conduct:
  • Oversee data collection/review metrics, evaluate SDTM definitions and mapping, perform data content and structure QC
  • Ensure inspectionreadiness and compliance with ICH-GCP, FDA regulations, EMA requirements, Data privacy regulations and Clinical trial industry standards
• Trial close-out:
  • Lead database lock planning and execution
  • Perform final QC on CRO deliverables
  • Ensure completeness of data submission package
  • Oversee transfer and archiving f the data management component of the Trial Master File.
• Follow up on trial timelines and budget from trial start through close out and elevate issues, if required
• Support regulatory submissions (BLA, MAA, ... ) and ensure the data is prepared according to the regulatory requirements.
• Support Head Data Management in the selection of DM Vendors and manage relationships with Vendors.
• Lead/participate in initiatives on process improvements
• Participate in regulatory agency and internal audits

• Timely setup of qualitative data collection tools
• Effective vendor oversight
• Timely delivery of scientifically sound clinical data, fit for statistical analysis, avoiding database reopenings
• Continuous process improvement achievements
• Successful inspections and audits

• Knowledge of ICH-GCP, EU and US regulatory requirements
• Knowledge of CDISC standards: SDTM and define.xml
• Knowledge of EDC platforms (e.g., Medidata Rave, Veeva EDC, ...)
• Accuracy/Precision: data review needs to be meticulous
• High-quality standards: an eye for detail
• Strong problem solving and analytical skills
• Strong communication and interpersonal skills
• Able to work independently as well as in a team environment
• MS Office: proficient level
• Fluent in English, written and spoken

• Expected educational qualifications: BS or MSc in relevant field of life sciences or equivalent by experience
• Expected experience: 10+ years of Clinical Data Management experience within pharmaceutical, biotechnology, or CRO environments with at least 3 years in study leadership role