Job Title: Clinical Data Manager
Location: Gaithersburg, MD (Remote Role)
Duration: 06 Months contract (Possible Extension)
• 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 client's 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 client 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 5calendar 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.
• 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 client values and behaviours
• Excellent organizational and analytical skills
• Demonstrated ability to work effectively with external partners
• Ability to interact effectively with all levels of management