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100% Remote Clinical Data Manager

Our client is seeking to bring on a group of Clinical Data Managers with a strong background in oncology to join thier team on a 100% remote/work from home basis. Individuals with CCDM Certification as this is highly desireable.

Accountabilities

  • Serves as the expert in Clinical Research Data Management to provide oversight and advice to the clinical project team(s) regarding the DM activities and deliverables
  • Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization
  • Provides input to the DM related activities associated with regulatory inspections/audits
  • Provide DM business expertise and consultancy in the selection and use of software systems and vendors
  • Development and oversight of DM processes and standards and functional leadership:
  • Oversee quality and consistency with company strategies and standards across therapeutic areas
  • Works with the Standards Group to provide input into clinical project standards and processes based on industry best practices
  • Facilitates and manages valid change requests of project standards to the Standards Committee
  • Assesses company CRDM needs and areas of improvement and recommends changes to the operating model
  • May be asked to provide strategic DM expertise to Global Clinical Initiatives
  • Management and oversight of vendor performance.
  • Reviews, assesses and manages DM delivery against KPIs and overall DM performance
  • Provides input into the contract process for the CRDM vendor
  • Manages all DM timelines and DM Deliverables for assigned studies
  • Ensures DM billing is accurate and forwards recommendation to CDM for payment of invoices.

Operational Responsibilities

  • Accountable for the execution and overall quality of DM activities and deliverables.
  • Acts as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.
  • Provide guidance and supervision to Lead Data Managers/DM Team Leads working on the study (CRO or in-house)
  • Accountable for "real time" Data Management, ensuring that DM conducts initial reviews within 5 calendar days of a patient's data entering the EDC system, and manages the average query aging to no more than 30 calendar days.
  • Accountable for the overall quality and completeness of the Data Management Plan (DMP).
  • Responsible for working closely with the Centralized Data Monitoring (CDM) group to ensure quality and integrity of our most important data points.

Required

  • Education: Minimum of a BS in life sciences or computer science degree
  • CCDM certification
  • Strong Data Management experience in the Biotech/Pharma/CRO industry (at least 5 years)
  • Strong Oncology Therapeutic Expertise (at least 3 years)
  • Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities
  • Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
  • Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
  • Demonstrate understanding and experience in query management process and reconciliation activities

Desired

  • Demonstrated knowledge of clinical and pharmaceutical drug development process
  • State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
  • Demonstrated understanding of clinical data system design / development / validation and system interoperability.

Sthree US is acting as an Employment Business in relation to this vacancy.