Lead Clinical Data Manager

Responsibilities

• Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports.
• Manage high complex studies and support specific activities of studies managed by other data managers or consultants.
• Provide technical tutoring and supervise data managers and/or contractors assigned to clinical studies by conducting regular reviews of activity status.
• In-depth knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) and Case Report Tabulation Data Definition Specification (Define.xml).
• Manage and guide providers, setting requirements, preparing or reviewing Request for Proposals and monitoring performance.
• Regularly monitor data management costs of the assigned studies ensuring respect of budget.
• Define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results.
• Ensure all data collection systems for assigned projects are setup, tested and fit for purpose according to expectations and timelines.
• Define the strategy and lead the preparation of data package for regulatory submission.
• Represent data management for auditing and regulatory inspection.

Requirements

• Minimum 8+ years of experience in Clinical Data Management in CROs or Pharmaceutical Industry.
• Solid knowledge of drug development processes.
• Strong data management expertise.
• Excellent knowledge of Good Clinical Data practices, GCP and regulatory requirements.
• Experience with clinical databases, electronic data capture (EDC) systems, wearables, and sensors to collect data directly from patients.
• Advanced analytical and technical skills to interrogate and mine high volumes of data from a variety of sources.