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Lead Clinical Data Manager
Lead Clinical Data ManagerKatalyst Healthcares and Life Sciences • San Francisco, CA, United States
Lead Clinical Data Manager

Lead Clinical Data Manager

Katalyst Healthcares and Life Sciences • San Francisco, CA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

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
  • EHR data, data collected directly from patients, omics data, other secondary data)
  • dvanced analytical and technical skills to interrogate and mine high volumes of data from a variety of sources.

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
  • Excellent knowledge of Risk-Based approach
  • Knowledge of Real-World data sources and processes to collect / manage different types of sources.
  • Basic knowledge of Artificial Intelligence (AI)
  • Project Management skills
  • Excellence in planning and priorities setting
  • nalytical, problem-solving skills and ability to take ownership of decision-making
  • Strong commitment to quality
  • Excellent oral and written communication and presentation skills
  • bility 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 Systems.
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