Functional Process Owner EMR2EDC Global Clinical Solutions Technologies

AstraZeneca•Durham, NC

10d

About The Position

Key responsibilities Own the full lifecycle (design, development, implementation, maintenance and continuous improvement) of assigned Development Operations system processes. Develop and maintain high‑quality guidelines, user manuals, training materials, templates and toolkit documents . Provide expert advice, training and end‑user support on system processes and supporting documentation. Define, track and monitor KPIs for the allocated processes, using data to identify improvements and support cross‑functional optimization. Deliver Corrective and Preventive Actions (CAPA) to time and quality, acting on trends identified through Quality & Risk Management. Escalate risks and issues as required and support risk mitigation strategies. Ensure customer requirements are understood, critically evaluated, prioritized and addressed, providing clear rationale where needs cannot be met. Engage and influence internal and external stakeholders to drive process strategy, development and continuous improvement. Liaise with Process Owners, BPMO, Governance representatives and System Owners to ensure alignment with SOPs, higher‑level processes and system procedures . Provide input to BPMO and Process Owners on new SOPs and regulations affecting the process. Be an active member of relevant Governance Teams . Support audit and regulatory inspection planning, preparation and conduct. Promote creative and innovative ideas to drive performance and deliver new solutions for customers. Customer Service and Support Act as the primary point of contact for Development Operations GCS system processes within Study Teams. Understand the system processes, technologies and services used by Study Teams, including their needs and pain points, to provide guidance, remove barriers and identify improvement opportunities. Ensure effective resolution of system process issues that impact study delivery, engaging the appropriate process, technology and service experts and leveraging escalation routes and governance bodies. Share lessons learned and best practices with Study Teams and GCS colleagues to foster continuous improvement.

Requirements

Bachelor of Science (BSc) in a relevant discipline or equivalent experience.
Extensive experience in Drug Development within a pharmaceutical or clinical environment.
Strong business process, technology and clinical study information knowledge.
Strong operational knowledge of system processes in the clinical trial setting .
Demonstrated project management capabilities with a track record of delivering to time, cost and quality.
Ability to work collaboratively, motivate and empower others to meet individual, team and organizational objectives.
Experience in vendor management , working collaboratively with external partners for mutual benefit.
Excellent written and verbal communication , influencing, negotiation, collaboration, problem‑solving, presentation, mentoring and interpersonal skills.

Nice To Haves

Recognized expert reputation within the business and/or industry.
Experience using standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes and drive process optimization.
Experience in the development and management of business processes to enhance performance.
Comprehensive knowledge of ICH/GCP .
Extensive experience in validation of computerized systems in a regulated environment (preferably pharmaceutical), including validation documentation (plans, reports, test scripts) and knowledge of GxP, SOX and related requirements.
Strong experience with Quality Systems and Quality Management , including process definition and improvement, ideally within an Information Systems context.
Experience planning and implementing EMR2EDC middleware systems for clinical trials, including project management activities with study teams and/or sites.
Experience with Medidata Rave , including iMedidata user and site administration, report administration, core configuration, study build and edit check programming.

Responsibilities

Own the full lifecycle (design, development, implementation, maintenance and continuous improvement) of assigned Development Operations system processes.
Develop and maintain high‑quality guidelines, user manuals, training materials, templates and toolkit documents .
Provide expert advice, training and end‑user support on system processes and supporting documentation.
Define, track and monitor KPIs for the allocated processes, using data to identify improvements and support cross‑functional optimization.
Deliver Corrective and Preventive Actions (CAPA) to time and quality, acting on trends identified through Quality & Risk Management.
Escalate risks and issues as required and support risk mitigation strategies.
Ensure customer requirements are understood, critically evaluated, prioritized and addressed, providing clear rationale where needs cannot be met.
Engage and influence internal and external stakeholders to drive process strategy, development and continuous improvement.
Liaise with Process Owners, BPMO, Governance representatives and System Owners to ensure alignment with SOPs, higher‑level processes and system procedures .
Provide input to BPMO and Process Owners on new SOPs and regulations affecting the process.
Be an active member of relevant Governance Teams .
Support audit and regulatory inspection planning, preparation and conduct.
Promote creative and innovative ideas to drive performance and deliver new solutions for customers.
Act as the primary point of contact for Development Operations GCS system processes within Study Teams.
Understand the system processes, technologies and services used by Study Teams, including their needs and pain points, to provide guidance, remove barriers and identify improvement opportunities.
Ensure effective resolution of system process issues that impact study delivery, engaging the appropriate process, technology and service experts and leveraging escalation routes and governance bodies.
Share lessons learned and best practices with Study Teams and GCS colleagues to foster continuous improvement.