Medical Evidence Data Management Leader

2 weeks ago

Mississauga, Canada AstraZeneca Full time

**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 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 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
- 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 DM escalations related to deliverables during the study set-up, conduct, and close-out phase
- Responsible for proactive risk management and issue resolution/escalation connected to DM activities or technology
- Provides input to the DM related activities associated with regulatory inspections/audits
- Provides functional leadership to develop and maintain DM 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 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 ME
- Provides 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-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 with Programming 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
- Represents MEDM 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 so

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