Overview

Key responsibilities include oversight of outsourced data management & EDC activities by service providers, performing and coordinating internal study team data review, and delivery of fit for purpose clinical data in support of study milestones.

ESSENTIAL JOB FUNCTIONS:

  • Provide clear, consistent communication to Kura’s CROs and 3rd party Vendors with respect to data management deliverables and monitor performance against communicated expectations.
  • Coordinate internal team review and feedback during EDC builds and/or migrations and provide clear guidance to external DM and EDC build team throughout.
  • Accountable for DM task and milestone timelines
  • Responsible for ensuring data quality and integrity for clinical study data collection activities.
  • Work with clinical team to define and maintain the Kura Comprehensive Data Review Plan.
  • Lead Kura study team in the review of clinical study data per Comprehensive Data Review Plan.
  • Prepare and provide internal data listings and reports as required.
  • Review protocols for data collection and management feasibility.
  • Provide leadership to the study team with respect to data management activities throughout the study lifecycle: planning, start-up, conduct, close-out.
  • Accountable for the creation and delivery of DM documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.); ensure documentation is appropriately filed within the Trial Management File (TMF).
  • Review study budgets and provide input on data collection, cleaning, and reporting as it relates to development of vendor contracts
  • Partner with internal content experts to manage and coordinate data collection/maintenance with external vendors; ensure deliverables are identified and met according to project milestones and program/project objectives.
  • Responsible for tracking and documenting data management decisions.
  • Responsible for initiating and chairing meetings associated with assigned studies and initiatives
  • Provide support and contribute to the development of clinical trial timelines as it relates to data management activities.
  • Manage accruals tracking and vendor payments for data management activities.
  • Contribute to the development of departmental procedures documentation.
  • Complete other duties as assigned by the

JOB SPECIFICATIONS:

  • A./B.S. degree in Biology, Mathematics, Computer Science or related scientific field.
  • 5+ years’ experience in data management or relevant work in the pharmaceutical/biopharma industry.
  • Experience in oncology strongly preferred.
  • Experience in managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out)
  • Significant experience providing oversight for database migrations.
  • Experience with an NDA submission desirable
  • Strong project management skills
  • Strong vendor management skills (e.g. Biomarkers, Labs, Imaging, ECG).
  • Able to provide independent DM subject matter expertise to study teams and vendors in defining, managing, & delivering on DM obligations.
  • Experience working in 1 or more EDC platforms (Rave, InForm, etc.).
  • Experience working in a data integration/visualization platform (e.g. Saama, elluminate) desirable
  • Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Excellent interpersonal skills in addition to verbal and written communication skills.
  • Strong Excel skills, SAS experience a plus
  • Flexibility to travel up to approximately 5% of