Clinical Data Management Quality Leader - Remote

Gaithersburg, Maryland 20878

Post Date: 02/20/2018 Job ID: 27604 Industry: Other Area(s)

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
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