Medical Evidence Data Management Leader

5 months 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 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 ( 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 .

Date Posted

10-Jun-2024

Closing Date

27-Jun-2024

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