Functional Process Owner EMR2EDC Global Clinical Solutions Technologies

Key responsibilities

• Own the full lifecycle (design development implementation maintenance and continuous improvement) of assigned Development Operations system processes.
• Develop and maintain highquality guidelines user manuals training materials templates and toolkit documents.
• Provide expert advice training and enduser support on system processes and supporting documentation.
• Define track and monitor KPIs for the allocated processes using data to identify improvements and support crossfunctional 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 higherlevel 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

• 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.

Education skills and experience Essential

• 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 problemsolving presentation mentoring and interpersonal skills.

Desirable

• 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.

Date Posted

Closing Date

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