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.
- 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.
- 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.
- 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
- 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.