Job Description

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.

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, problem?solving, 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.