Agenus

Senior Data Manager

US-MA-Lexington
1 month ago
ID
2017-1304
Category
Development

Overview

Support CDM activities of all assigned Agenus' clinical studies

Responsibilities

  • Manage clinical trials data or data management projects under aggressive timelines in a high quality and professional manner. Identify requirements for capture and processing of clinical data ensuring accuracy, consistency and completeness while adhering to SOPs and work guidelines as required.
  • Oversee Data Management vendors – review and approve all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
  • Lead regular data review meetings in a cross-functional team environment.
  • Develop/review data management functional SOPs and processes.
  • Oversee the design, creation and testing of clinical study databases, responsible for creating and adhering to Data Management timelines and budget.
  • Review protocols for proper data capture including electronic Case Report Form design. Able to perform a thoroughly detailed review of eCRF data requirements. Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans etc.
  • Designs and/or reviews eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans, Data Surveillance Plan, detailing complete data management processes throughout clinical studies.
  • Create/Oversee development of data edit check specifications and manual data listings as required.
  • Responsible for data cleaning, query and resolutions, review of medical coding, database lock activities
  • Responsible for lab reconciliation, manage and reconcile external data, authoring data transfer agreements, and ensuring study documentation to be filed in the eTMF
  • Working with Safety/PV function to develops study specific Serious Adverse Event (SAE) reconciliation guidelines, reconciles SAEs, comparing events across the clinical database and drug safety database, addressing any discrepancies, as per SAE guidelines
  • Possesses solid computer system and technical skills with a strong ability to learn multiple e computer applications. Prior experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards are desirable.
  • Proficient working knowledge of any of the following strongly desired: SAS, Spotfire or other Visualization Tools, Data Standards management, SDTM

Qualifications

  • Bachelor or Master degree in a health care or related field
  • Minimum 5 years of clinical data management experience within Biopharma/CRO environment. Oncology/Immuno-Oncology experience is preferred.
  • Team player who effectively works with colleagues in clinical, clinical operation, and statistics function

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