Senior Manager CDM

144832
  • 150000 USD - 150000 USD
  • Menlo Park, United States
  • Permanent

Senior Manager, Clinical Data Management

Position Summary

Meet is seeking a Senior Manager, Clinical Data Management (CDM) to join our exciting client working on a spread of therapeutic areas. They are working on Autoimmune, Ophthalmology and Neurology.

This individual will play a crucial role in ensuring accurate, high-quality clinical trial data within a fast-paced, cross-functional team environment. The role encompasses supporting clinical data management activities from study start-up through closure, aligned with trial objectives and corporate goals. This position will report to the Director or Associate Director of CDM.

Responsibilities

  • Lead Data Management activities for multiple clinical studies.
  • Oversee and manage vendor Data Management (DM) as needed.
  • Maintain data quality and integrity from study initiation to database lock.
  • Review study protocols and assist in planning and implementing data management aspects.
  • Design CRFs/eCRFs for comprehensive data collection through the regulatory approval process.
  • Train personnel on eCRFs and EDC systems as necessary.
  • Author and maintain essential DM documents including Data Management Plans, Data Transfer Plans, and Data Review Plans.
  • Lead data review, query management, and report DM metrics to ensure data completeness, correctness, and consistency.
  • Actively participate in Clinical Study Teams (CST).
  • Collaborate with other functions to develop timelines and ensure DM deadlines are met.
  • Coordinate with vendors such as central laboratories to support timelines and data-related deliverables.
  • Review and reconcile laboratory data and associated lab normal ranges.
  • Define eCRF and edit check specifications to support protocol-required data collection and analysis.
  • Work closely with database builders during EDC database programming, edit checks, and report generation.
  • Drive and perform User Acceptance Testing (UAT) for clinical trial database builds and modifications.
  • Develop study-specific eCRF Completion Guidelines.
  • Create and follow study-specific Data Management Plans.
  • Maintain data management documentation.
  • Ensure data cleaning activities per Data Validation Specifications and Data Management Plan.
  • Coordinate with coding groups to ensure accurate application of medical terminology coding to clinical studies.
  • Support data analytics implementation for clinical and medical data review.
  • Train assigned data reviewers in data review processes.
  • Collaborate with cross-functional team members on serious adverse event reconciliation.
  • Contribute to the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management.
  • Maintain eTMF for DM documentation and perform archiving of study database and documentation.
  • Perform additional duties as assigned.

Key Qualifications

  • Bachelor's degree in a scientific subject area preferred.
  • Minimum of 8 years of clinical data management experience in biotechnology or pharmaceutical industry.
  • At least 6 years of experience with Electronic Data Capture (EDC); IXRS development preferred.
  • Proficient computer skills, including Microsoft Office applications.
  • Strong knowledge of Data Management processes and systems.
  • Solid understanding of clinical drug development processes.
  • Demonstrated problem-solving abilities in a team environment.
  • Strong organizational skills and ability to work in a fast-paced environment.
  • Proficient in cross-functional collaboration with Biostatistics, Statistical Programming, Pharmacovigilance, and Clinical Operations.
  • Excellent written and verbal communication skills.
  • Knowledge and experience with ICH, GCP, and CDASH/CDISC.
  • Experience with Medidata Rave preferred.
  • Experience with elluminate® or comparable analytics software preferred.
  • Familiarity with MedDRA and WHODrug coding.
  • Experience in regulatory submissions and inspections is a plus.
  • Willingness to travel occasionally.
  • Bay Area local candidates will only be considered.
Thomas Huynh Resourcer

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