AstraZeneca
Job title:
BPM Evidence Delivery Data Management Associate Director
Company
AstraZeneca
Job description
Business areaMedical Evidence studies include primary and secondary data collection studies, including but not limited to, interventional and observational studies, and Real World Evidence.About the role:The Medical Evidence Data Management Leader (MEDML) will be responsible for the oversight of the Medical Evidence Data Management (MEDM) delivery of high-quality data via external partners for assigned Medical Evidence studies, which includes (but is not limited to) supervision of communication, specifications, and documentation.The MEDML is accountable for the overall quality and integrity of the database, and they work collaboratively to ensure that the data is collected and managed clearly, accurately, and securely based on the study protocol and to the highest scientific industry standards, thus ensuring the quality of the data to be reported.The MEDML serves as the core member of the evidence team for all aspects pertaining to DM and data quality.The MEDML acts as an expert on data management processes, projects and technology, maintains an up-to-date awareness of trends/changes in external data management approaches, and serves as a subject matter expert in process development and improvement.The number of studies assigned to a MEDML will be based on the therapeutic area, size, complexity and the delivery model.Roles & Responsibilities:Manages and oversees of external partnersResponsible for managing stakeholders and collaborators understanding and expectations of all aspects of MEDMReviews, assesses and manages overall data management (DM) vendor’s performance and deliveryEnsures that DM vendor abides by AstraZeneca (AZ) procedural requirements on data and governanceOversees completeness and quality of DM documentationProvides guidance and supervision to DM vendor’s representatives working on the studyManages and resolves issues related to DM by developing solutions to complex problems to ensure consistency across the organizationSupervises all DM timelines and deliverables in relation to timeliness, cost, and qualityProvides advice and DM oversight to the evidence team(s) regarding the DM activities and deliverablesDemonstrates a business understanding of the study needs to identify and assist in successful application of consistent DM processes and documentation across assigned programsProvides input into the contract process for the DM vendorAccountable for the oversight and overall quality of DM activities and deliverablesActs as the point of contact for all DM escalations related to deliverables during the study set-up, conduct, and close-out phaseResponsible for proactive risk management and issue resolution/escalation connected to DM activities or technologyProvides input to the DM related activities associated with regulatory inspections/auditsProvides functional leadership to develop and maintain DM processes and standardsOversees quality and consistency with AZ data collection strategies and standards as well as integrity within therapeutic areasServes as a Subject Matter Expert (SME) for ME pertaining to DM processes and requirements in line with good practice and industry standards; including input into processes, ways of working and SOPs specific to MEProvides DM expertise in supporting strategic and operational aspects of MEDM, including but not limited to primary and secondary data collection evidence activities and Real World Data use and data re-useProvides DM business expertise and consultancy in the selection and use of software systems and vendorsUnderstands CDASH, SDTM, ADaM, and other recognized industry standards to liaise smooth cooperation with Programming and Standards groupsWorks with the AZ Standards group to provide input into data standards and processes based on industry best practicesSupports the development of and use of the ME Standards Library, where relevantFacilitates and manages valid change requests of project standardsUnderstands health authority requirements and provide input into the MEDM related activities associated with regulatory inspections/audits and liaison with Quality Assurance (QA)Aligns aspects of DM and governance with practice in ME, liaises with other Business Units (e.g. R&D) to share experiences, lessons learned, and solutions to problemsMay provide coaching, training, and mentoring to other MEDM colleagues and stakeholder with regards to operational processes used in ME studiesRepresents MEDM at cross functional forums, meetings, and provides timely feedback to partnersRequirements:Education: Minimum of a BS in life sciences or computer science degree. Experience may be substituted for education.Data Management experience in the Biotech/Pharma/CRO industryDemonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activitiesDemonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and Real World Evidence landscapeExperience of databases, different clinical data management systems, and electronic data capture (EDC)Demonstrate understanding and experience in query management process and reconciliation activitiesStrong communication and interpersonal skillsExcellent written and verbal communication skillsEffective problem and conflict solving skillsAbility to work in a global team environmentHigh attention to detail and accuracyAbility to work independently under limited direction from supervisorsDesirable skills & experience:Certified Clinical Data Manager (CCDM) via the Society of Clinical Data ManagementDemonstrated knowledge of clinical and pharmaceutical drug development processState of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reportingDemonstrated understanding of clinical data system design / development / validation and system interoperability.Excellent understanding and demonstration of the AZ values and behaviorsExcellent organizational and analytical skillsDemonstrated ability to work effectively with external partnersAbility to interact effectively with all levels of managementGreat People want to Work with us! Find out why:Are you interested in working at AZ, apply today!AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .Date Posted 13-Sept-2024Closing Date 03-Oct-2024AstraZeneca 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 authorization and employment eligibility verification requirements.
Expected salary
Location
Mississauga, ON
Job date
Sat, 14 Sep 2024 22:02:37 GMT
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