Lead Clinical Data Manager
- 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.
- 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.
- Proficiency in SAS System.
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