Medical Evidence Data Management Leader
Business area
Medical 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 overseesof external partners
Responsible for managing stakeholders and collaborators understanding and expectations of all aspects of MEDM
Reviews, assesses and manages overall data management (DM)vendor's performance and delivery
Ensures that DM vendor abides by AstraZeneca (AZ) procedural requirements on data and governance
Oversees completeness and quality of DM documentation
Provides guidance and supervision to DM vendor's representatives working on the study
Manages and resolves issues related to DM by developing solutions to complex problems to ensure consistency across the organization
Supervises all DM timelines and deliverables in relation to timeliness, cost, and quality
Provides advice and DM oversight to the evidence team(s) regarding the DM activities and deliverables
Demonstrates a business understanding of the study needs to identify and assist in successful application of consistent DM processes and documentation across assigned programs
Provides input into the contract process for the DM vendor
Accountable for the oversight and overall quality of DM activities and deliverables
Acts as the point of contact for all DMescalations related to deliverables during the study set-up, conduct, and close-out phase
Responsible for proactive risk management and issue resolution/escalation connected to DMactivities or technology
Provides input to the DM related activities associated with regulatory inspections/audits
Provides functional leadership todevelop and maintainDM processes and standards
Oversees quality and consistency with AZ data collection strategies and standards as well as integrity within therapeutic areas
Serves as a Subject Matter Expert (SME) for MEpertaining toDM processes and requirements in line with good practice and industry standards; including input into processes, ways of working and SOPs specific to ME
Provides DMexpertise 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-use
Provides DM business expertise and consultancy in the selection and use of software systems and vendors
Understands CDASH, SDTM,ADaM, and other recognized industry standards to liaise smooth cooperation withProgramming and Standards groups
Works with the AZ Standards group to provide input into data standards and processes based on industry best practices
Supports the development of and use of the ME Standards Library, where relevant
Facilitates and manages valid change requests of project standards
Understands 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 problems
May provide coaching, training, and mentoring to other MEDM colleagues and stakeholder with regards to operational processes used in ME studies
RepresentsMEDM at cross functional forums, meetings, and provides timely feedback to partners
Requirements:
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 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) and Real World Evidence landscape
Experience of databases, different clinical data management systems, and electronic data capture (EDC)
Demonstrate understanding and experience in query management process and reconciliation activities
Strong communication and interpersonal skills
Excellent written and verbal communication skills
Effective problem and conflict solving skills
Ability to work in a global team environment
High attention to detail and accuracy
Ability to work independently under limited direction from supervisors
Desirable skills & experience:
Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
Demonstrated 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
Demonstrated understanding of clinical data system design / development / validation and system interoperability.
Excellent understanding and demonstration of the AZ values and behaviors
Excellent organizational and analytical skills
Demonstrated ability to work effectively with external partners
Ability to interact effectively with all levels of management
Great 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 AZCHumanResources@astrazeneca.com.
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 authorization and employment eligibility verification requirements.
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