Job Description

• The Lead Data Manager is responsible for overseeing data management activities for assigned clinical projects, ensuring the implementation of data strategy and governance.
• This role involves acting as a technical leader, managing data quality, and ensuring compliance with regulatory standards.
• The Lead Data Manager will also define strategies for data submission and represent data management during audits and regulatory inspections.
• Plan and drive the conduct of all Data Management activities for assigned project(s) ensuring a consistent approach across studies.
• 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.
• 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.
• Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports.
• Define the strategy and lead the preparation of data package for regulatory submission.
• Represent data management for auditing and regulatory inspection.
• EHR data, data collected directly from patients, omics data, other secondary data).
• 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).
• Advanced analytical and technical skills to interrogate and mine high volumes of data from a variety of sources.

• Minimum 10 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.
• Excellent knowledge of Risk-Based approach.
• Knowledge of Real-World data sources and processes to collect/manage different types of sources (e.g.)
• Project Management skills.
• Excellence in planning and priorities setting.
• Analytical, problem-solving skills and ability to take ownership of decision-making.
• Strong commitment to quality.
• Excellent oral and written communication and presentation skills.
• Ability to collaborate and work in a team-based environment.
• Courage, resilience, and ability to adjust to a rapidly changing environment.
• Experience with Medidata platform.
• Familiarity with other platforms for secondary data

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