- To provide CDM subject matter expertise to the study team(s) and is responsible for overseeing and managing all CDM activities for the study.
- Serves as a core team member of the Global Study Team(s) and is accountable for all CDM-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 clinical database, and they work collaboratively to ensure that AstraZeneca's 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 the expert in Clinical Data Management to provide oversight and advice to the clinical project team(s) regarding the CDM activities and deliverables
- Manages and resolves issues related to CDM deliverables by developing solutions to complex problems to ensure consistency across organization
- Provides input to the CDM related activities associated with regulatory inspections/audits
- Provide CDM business expertise and consultancy in the selection and use of software systems and vendors
- Development and oversight of CDM processes and standards and functional leadership:
- Oversee quality and consistency with AstraZeneca 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 AstraZeneca CDM needs and areas of improvement and recommends changes to the operating model
- May be asked to provide strategic CDM expertise to Global Clinical Initiatives
- Management and oversight of vendor performance.
- Reviews, assesses and manages CDM delivery against KPIs and overall DM performance
- Provides input into the contract process for the CRDM vendor
- Manages all CDM timelines and CDM Deliverables for assigned studies
- Ensures CDM billing is accurate and forwards recommendation to CDM for payment of invoices
- Operational Responsibilities
- 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 CDM 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 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
- 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
- Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
- 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 AZ 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
Next step - Apply today!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.