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Senior Data Manager

Job Title

Senior Data Manager

Job Status

Full Time

Job Summary

This position provides tactical direction for data management activities across all projects in all phases of development. Supports high quality conduct of Data Management activities for Elevar Therapeutics projects, from program design via protocol development and study execution through to NDA/MAA Submissions and post-approval support, working closely with Clinical Operations and Statistics/Statistical Programming functional areas.

Job Details

  • Enable achievement of major data management deliverables and data milestones for oncology programs in coordination with other functions including Medical, Clinical Operations, Pharmacovigilance, Biostatistics and Statistical Programming
  • Provide support of data management deliverables (i.e. database design, critical data checks and validation)
  • Responsible for the quality of the data in each clinical database, as well as quality of other data management deliverables
  • Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
  • Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements
  • Review data analysis listings and report on performance and quality
  • Design forms for receiving, processing, or tracking data
  • Coordinate CRF design as per established standards and applicable protocol
  • Support the data collection through efficient eCRF and database design
  • Manage and track CRF flow and scanning and input required data
  • Test clinical database, including testing logic checks
  • Ensure documentation and archival of data management deliverables
  • Manage all CRO Data Management activities, as needed
  • Monitor work productivity and/or quality of CROs, consultants, etc. to ensure compliance with Elevar Therapeutics standard operating procedures.
  • Provide input into other relevant functional groups’ activities and participates in interdepartmental processes

Candidate Requirements (External)

  • BS in a relevant field
  • 6+ years of experience in pharmaceutical, biotech or equivalent; global experience strongly preferred
  • Strong analytical, detail-oriented mindset, ability to solve moderate to complex problems
  • Working knowledge of data management principles, including knowledge of relevant Data Standards (i.e. CDISC/ADaM)
  • Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports
  • Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry
  • Excellent written communication skills, including competent grammatical/technical writing ability
  • Excellent oral/interpersonal communication skills, including public speaking/presenting ability
  • Strong independent work ethic
  • Strong organizational skills
  • Strong teamworking ability
  • Fluent in English (oral and written)

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Manager, Quality Assurance


LSK BioPharma Announces New Corporate Name: Elevar Therapeutics