Clinical Data Management Quality Leader - Remote
25 W. Watkins Road Ã¢ÂÂ 403A Gaithersburg, Maryland 20878
Clinical Data Management Quality Leader - remote
• To provide DM subject matter expertise to the study team(s) and is responsible for overseeing and managing all DM activities for the study.
• Serves as a core team member of the study team(s) and is accountable for all DM-related communications, specifications, and documentation that includes but not limited to the Data Management Plan (DMP).
• The DMQL is responsible for the overall quality and integrity of the database with respect to “ Critical to Quality” (CTQ) data points predefined by Clinical and Biostats prior to the start of a study.
• The DMQL will “ project manager” the Data Quality Plan to ensure CTQ data points are of the highest integrity and completeness.
• Number of studies assigned to DMQL will be based on a given therapeutic area, depending on size, complexity and working model.
• 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 o Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization o Provides input to the DM related activities associated with regulatory inspections/audits o 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: o Oversee quality and consistency with strategies and standards across therapeutic areas o Works with the Standards Group to provide input into clinical project standards and processes based on industry best practices o Facilitates and manages valid change requests of project standards to the Standards Committee o Assesses CRDM needs and areas of improvement and recommends changes to the operating model o May be asked to provide strategic DM expertise to Global Clinical Initiatives
• Management and oversight of vendor performance. o Reviews, assesses and manages DM delivery against KPIs and overall DM performance o Provides input into the contract process for the CRDM vendor o Manages all DM timelines and DM Deliverables for assigned studies o Ensures DM billing is accurate and forwards recommendation to CDM for payment of invoices.
• Operational Responsibilities o Accountable for the execution and overall quality of DM activities and deliverables. o 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. o Provide guidance and supervision to Lead Data Managers/DM Team Leads working on the study (CRO or in-house) o 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. o Accountable for the overall quality and completeness of the Data Management Plan (DMP). o Responsible for working closely with the Centralized Data Monitoring (CDM) group to ensure quality and integrity of our most important data points.
-Minimum of 5 years experience in related field
-Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management in Oncology
• Education: Minimum of a BS in life sciences or computer science degree
• 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 • Strong communication and interpersonal skills
• Ability to work independently under direction and close supervision
• Excellent written and verbal communication skills
• Effective problem and conflict solving skills
• Ability to work in a global team environment
• High attention to detail and accuracy
• 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.
• Excellent understanding and demonstration of the values and behaviors
• Excellent organizational and analytical skills
• Demonstrated ability to work effectively with external partners
• Ability to interact effectively with all levels of management