Prinicipal Clinical Study Data Manager
At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need phenomenal people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
The Principal Clinical Data Manager provides CDM subject matter expertise to the study team(s) and is responsible for supervising and leading all CDM activities.
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 PCDM 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 PCDM will be based on a given therapeutic area, depending on size, complexity and working model.
- Serves as the specialist in data management to provide oversight and advice to the clinical project team(s): leads and resolves issues related to CDM results by developing solutions to complex problems to ensure consistency across organization; provides input to related activities associated with regulatory inspections/audits and business expertise and consultancy in the selection and use of software systems and vendors
- Development and oversight of processes, standards and functional leadership: lead all aspects of quality and consistency with AstraZeneca strategies and standards across therapeutic areas; works with the Standards Group and Standards Committee to provide input into clinical project standards, facilitates and leads valid change requests
- Assesses AstraZeneca needs and areas of improvement - recommends changes to the operating model, may be asked to provide strategic expertise to Global Clinical Initiatives
- Management vendor performance - reviews, assesses and leads delivery against meaningful metrics and overall DM performance; provides input into the contract process for vendors
- Leads timelines and results for assigned studies; ensures CDM billing is accurate and forwards recommendation for payment of invoices
- Accountability for the execution and quality of DM activities and results.
- Acts as the single point of contact for all data management results for the study team during the study set-up phase, CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities
- Provide mentorship and supervision to Lead Data Managers/DM Team Supervises working on the study (CRO or in-house)
- Accountable for “real time” Data Management and overall quality and completeness of data
- Responsible for working closely with the Centralized Data Monitoring group to ensure quality and integrity of our most significant data points
- Education: minimum of a BS in life sciences or computer science degree
- Strong Data Management experience in the Biotech/Pharma/CRO industry
- Shown current understanding of Good Clinical Data Management Practices (GCDMP), GCP and regulatory requirements
- Experience of clinical databases, different systems and electronic data capture (EDC), demonstrate understanding and experience in query management process and reconciliation activities
- Proven track record of effective work with external partners and vendors
- Strong communication and social skills - excellent written and verbal communication, effective problem solving skills, ability to work in a truly global environment
- Ability to work independently and as part of a team
- High attention to detail and accuracy
- Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
- Confirmed 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
- Proven understanding of clinical data system design / development / validation and system interoperability.
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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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.