Us
Pharmaceutical
AssociateDirector,GCSBusinessTechnologySolutions(EDCPlatform)
Neural analysis suggests this role is
optimal for Director candidates.
“Associate Director, GCS Business Technology Solutions (EDC Platform) at Us. Skills: EDC Platform Leadership, Lifecycle Management, Customer Experience, Collaborator Engagement. Lead EDC platform design. Develop EDC platform”
What You'll Achieve.
Reduce cycle time; Raise data quality; Simplify user experience; Deliver measurable value at portfolio scale; Ensure consistent, inspection-ready study delivery; Reduce risk; Strengthen audit readiness; Drive user happiness through clear service levels; Elevate capability across internal teams and partners; Align technology decisions to clinical priorities and portfolio needs; Make transparent trade-offs; Improve processes; Shorten timelines; Improve data quality; Improve user experience; Deliver CAPAs to time and quality; Act on trends surfaced through Quality and Risk Management; Boost productivity; Deliver measurable business value; Turn brand new science into real-world impact; Elevate how studies are delivered; See ideas translate into faster, higher-quality trials
Industry & Context.
Problem solving skills
What They're Looking For.
Must Have
Bachelor’s of Science in an appropriate subject area or equivalent experience, Extensive knowledge of Drug Development within a pharmaceutical or clinical background, High level of business process, technology and Clinical Study information experience, Demonstrated project management skills to deliver to time, cost and quality, Ability to collaborate with, and motivate and empower others to accomplish individual, team and organisational objectives, Experience in working successfully with external partners delivering mutual benefit, Demonstrated excellent written, verbal and influencing skills, Negotiation skills, Collaboration skills, Problem solving skills, Presentation skills, Knowledge transfer (mentoring) skills, Conflict management skills, Interpersonal skills, Experience in Medidata Rave including iMedidata user and site administration, Report administration, Core configuration, Study build, Edit check programming
Nice to Have
Expert reputation within the business and industry, Experience of utilising standard process improvement methodologies (e. g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement, Experience in the development and management of Business Processes to deliver business performance, Comprehensive knowledge of ICH/GCP, Extensive experience in Validation of computerised systems in a regulated environment, preferably the Pharmaceutical industry, Familiarity with documentation such as Validation Plans, Reports, Test scripts etc., Knowledge of regulatory (GxP, SOX etc. ) requirements for computerised systems and infrastructure, Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment, Ability to set and manage priorities, resources, performance targets and project initiatives in a regional environment, Medidata Study Builder certification, Experience in other EDC systems (e. g Veeva, Bioclinica), Experience in other Medidata products including Rave EDC, Site Cloud, Medidata Coder, RSG, RAVE Imaging, Experience of working within agile environment, Experience of using JIRA
What You'll Do.
Lead EDC platform design
Implement EDC platform
Maintain EDC platform
Set platform standards
Own lifecycle management
Ensure regulatory compliance
Provide customer support
Resolve issues quickly
Raise concerns appropriately
Produce training materials
Influence collaborators
Steer platform strategy
Align technology decisions
Translate requirements
Challenge requirements
Prioritize requirements
Communicate rationale
Promote creative ideas
Promote new solutions
Deliver business value
How You'll Work.
Team & Collaboration
Working across Clinical Operations, quality, data management and external partners; Collaborate with, and motivate and empower others; Working successfully with external partners; Engage and influence internal and external collaborators; Work with GCS and Clinical Operations leadership; Work with colleagues from clinical operations, data science, engineering and quality
Communication Scope
Excellent written, verbal and influencing skills; Presentation skills; Knowledge transfer (mentoring)
Process & Methodology
Demonstrated project management skills to deliver to time, cost and quality, Ability to set and manage priorities, resources, performance targets and project initiatives
Full Job Description
# Job Title: Associate Director, GCS Business Technology Solutions (EDC Platform) **Introduction to role:** Are you ready to harness digital data capture to accelerate clinical development and bring medicines to patients faster? As Associate Director, GCS Business Technology Solutions (EDC Platform), you will own the strategy, reliability and evolution of our enterprise Electronic Data Capture capability, ensuring our studies are built, run and reported with quality, speed and compliance. You will guide the lifecycle of the Medidata Rave platform—governing configuration standards, advancing automation and analytics, and embedding continuous improvement techniques such as Lean Six Sigma. Working across Clinical Operations, quality, data management and external partners, you will translate complex requirements into scalable solutions that reduce cycle time, raise data quality and simplify the experience for thousands of global users. Do you thrive at the intersection of clinical operations, technology and change leadership? This is your chance to shape how we deliver end-to-end clinical studies and to unlock measurable value at portfolio scale. **Accountabilities:** \- EDC Platform Leadership: Lead the design, development, implementation and maintenance of our Medidata Rave EDC platform and adjacent services; set vision and standards that enable consistent, inspection-ready study delivery. \- Lifecycle Management and Compliance: Own lifecycle management of system documentation and validation work; ensure full compliance with regulations and AstraZeneca policies, reducing risk and strengthening audit readiness. \- Customer Experience and Support: Provide ongoing customer support to global study teams; resolve issues quickly, raise concerns appropriately and drive user happiness through clear service levels. \- Training and Knowledge Transfer: Produce high-quality training materials and deliver engaging training and mentoring that elevate capability across internal team
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