AstraZeneca Pharmaceuticals LP Data Management Quality Lead in Mississauga, Ontario
At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.
Our purpose is bold and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal.
Provides DM leadership and subject matter expertise to the study team(s) and is responsible for leading all DM activities for the study
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.
The DMQL will typically be assigned to no more than 4 studies within a given therapeutic area, depending on size and complexity.
Serves as the authority in Clinical Research Data Management to provide oversight and advice to the clinical project team(s) regarding the CRDM activities and deliverables
Handles and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization
Provides input to the CRDM related activities associated with regulatory inspections/audits
Provide CRDM 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
Lead 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 to improve ways of working
Facilitates and manages valid change requests of project standards to the Standards Committee
Assesses AstraZeneca CRDM needs and areas of improvement and recommends changes to the operating model
May be asked to provide strategic DM expertise to Global Clinical Initiatives
Management and oversight of vendor contracts, resourcing and budgets
Reviews, assesses and executes DM delivery against metrics and overall DM performance
Provides input into the contract process for the CRDM vendor
Ensures all DM timelines and DM Deliverables for assigned studies are met
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 working on the study (CRO, Cognizant, or in-house)
Accountable for “real time” Data Management, ensuring that DM conducts initial reviews within 5 days of a patient’s data entering the EDC system, and manages the average query aging to no more than 20 days.
Accountable for the overall quality and completeness of the Data Management Plan (DMP).
Responsible for working closely with the Centralized Data Monitoring (CDM) group to ensure quality and integrity of our most important data points.
Successful individuals will possess a BS in life sciences or computer science degree
Strong Data Management experience in the Biotech/Pharma/CRO industry
Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management (Preferred)
Demonstrated knowledge of clinical and pharmaceutical drug development process
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)
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
Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
Demonstrated understanding of clinical data system design / development / validation and system interoperability.
Demonstrated leadership (including in an outsourced environment)
Excellent understanding and demonstration of the AZ values and behaviours
Demonstrated project management skills
Strong communication and interpersonal skills
Excellent organizational and analytical skills
Ability to work independently
Demonstrated ability to work effectively with external partners
Ability to negotiate and influence others across functional areas
Excellent written and verbal communication skills
Effective problem and conflict solving skills
Ability to work in a global team environment
Ability to interact effectively with all levels of management
High attention to detail and accuracy
Applicants who meet the minimum requirements as outlined above, will progress in our recruitment process.
Internal applicants who are interested in this position are advised to inform their manager before they apply.
AstraZeneca Canada Inc. is an equal opportunity employer in accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, AstraZeneca will provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities. If selected to participate in the recruitment, selection and/or assessment process, please inform the Talent Acquisition Partner of your accommodation(s) need(s) to ensure your equal participation