Clinical Research Data Management Quality Leader
Warszawa Clinical Research Data Management Quality Leader
Warszawa
NR REF.: 1099854
About Us
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Real World Evidence Senior Data Scientist/Data Scientist you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives.
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:
Minimum experience:
Preferred experience/requirements:
We offerstable employment conditions, wide benefit package and the opportunity to participate in building a new team .If you would like to apply for the above position, please send your application documents (actual curriculum vitae) in English.
Warszawa
NR REF.: 1099854
About Us
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Real World Evidence Senior Data Scientist/Data Scientist you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives.
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 experience:
- Minimum of a BS in life sciences or computer science degree
- Strong Data Management experience in the Biotech/Pharma/CRO industry
Preferred experience/requirements:
- 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
We offerstable employment conditions, wide benefit package and the opportunity to participate in building a new team .If you would like to apply for the above position, please send your application documents (actual curriculum vitae) in English.
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