AstraZeneca Pharmaceuticals LP Clinical Research Data Management Quality Leader (DMQL) in Warsaw, Poland
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
We are looking for a Data Management Quality Leader (DMQL), located within Clinical Research Data Management, Clinical Operations in Global Medicines Development in Warsaw.
As a Data Management Quality Leader (DMQL) you will ensure that all clinical data management tasks in your studies will be delivered to time, quality and cost.
As a member of the study team(s), you will provide Clinical Research Data Management (DM) leadership and subject matter expertise to the study team(s) and you will be responsible for overseeing and managing all DM activities for the study, including.communications, specifications, and documentation. You will be responsible for the overall quality and integrity of the clinical database with respect to critical to quality data points predefined by Clinical and Biostatistics prior to the start of a study.
Major Duties and Responsibilities:
Expertise in Clinical Research Data Management (DM) to provide oversight and advice to the clinical study team(s) regarding the DM activities and deliverables
Development and oversight of DM processes and standards and functional leadership:
Management and oversight of vendor contracts, resourcing and budgets
Accountability for the execution and overall quality of DM activities and deliverables.
Responsibility for acting 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.
Guidance and supervision to Lead Data Managers working on the study (Cognizant, Contract Research Organisation or in-house)
Responsibility for working closely with the Centralized Monitoring group to ensure quality and integrity of our most important data points.
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)
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
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.