Serves as an extended team member of the evidence team(s) and is responsible for oversight of for all data management (DM) related communications, specifications, and documentation that includes but not limited to the Data Management Plan (DMP)
The GDML is responsible for the overall quality and integrity of the database, and they work collaboratively to ensure that Clinical Data is collected, managed, and reported clearly, accurately, and securely based on the study’s protocol and to the highest scientific industry standards
Number of studies assigned to GDML will be based on a given therapeutic area, depending on size, complexity and working model.
Serves as a subject matter expert for Medial Evidence pertaining to data management processes and requirements in line with good practice and industry standards
Provides oversight and advice to the evidence 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 in Medical Evidence to:
Oversee quality and consistency with strategies and standards across therapeutic areas
Works with the Standards Group to provide input into standards and processes based on industry best practices
Facilitates and manages valid change requests of project standards to the Standards Committee
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 DM vendor
Manages all DM timelines and DM Deliverables for assigned studies
Ensures DM billing is accurate and forwards recommendation to DM for payment of invoices.
Accountable for the oversight and overall quality of DM activities and deliverables.
Acts as the single point of contact for all data management deliverables for the evidence team during the study set-up phase, supporting and advising on 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 the overall quality and completeness of the Data Management Plan (DMP).
Education: Minimum of a BS in life sciences or computer science degree
Data Management experience in the Biotech/Pharma/CRO industry
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 TFS 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
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