Astrazeneca India Private Limited

Associate Director - Electronic Data Capture (EDC) Platform

Astrazeneca India Private Limited
Bengaluru/Bangalore
Not disclosed
Work from OfficeWork from Office
Full TimeFull Time
Min. 5 yearsMin. 5 years

Job Description

Associate Director, GCS Business Technology Solutions (EDC Platform)

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 teams and partners.
- Collaborator Engagement and Strategy: Engage and influence internal and external collaborators to steer platform strategy and roadmaps; align technology decisions to clinical priorities and portfolio needs.
- Requirements Prioritization and Governance: Translate, challenge and prioritize customer requirements; work with GCS and Clinical Operations leadership to make transparent trade-offs, allocate resources and communicate rationale.
- Define, track, and monitor important metrics. Use data to find bottlenecks and improve processes. These improvements shorten timelines and improve data quality and user experience.
- Audit and Inspection Readiness: Plan, prepare and support audits and regulatory inspections; deliver CAPAs to time and quality and act on trends surfaced through Quality and Risk Management.
- Innovation and Value Creation: Promote creative ideas and new solutions—automation, configuration standards, and reusable components—to boost productivity and deliver measurable business value.

Essential Skills/Experience:
- 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. Also have experience in working successfully with external partners delivering mutual benefit
- Demonstrated excellent written, verbal and influencing skills. Also negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.
- Experience in Medidata Rave including iMedidata user and site administration, report administration, core configuration, study build and edit check programming.

Desirable Skills/Experience:
- 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, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and 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, including experience of using JIRA.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:
Join a research-led company where data, technology and science come together to tackle complex diseases at scale. You will work with colleagues from clinical operations, data science, engineering and quality who collaborate openly, test ideas fast and learn continuously. We back bold thinking with the tools, platforms and pipeline of a leading innovator, and we value kindness alongside ambition—so you can take smart risks while making a direct difference to patients. Here, your expertise in EDC will build how studies run globally and help turn brand new science into real-world impact.

Call to Action:
If you are ready to lead a critical platform, elevate how studies are delivered and see your ideas translate into faster, higher-quality trials, we want to hear how you will make it happen.

Date Posted

19-May-2026

Closing Date

01-Jun-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Experience Level

Mid Level

Job role

Work location
Work locationIndia - Bangalore
Department
DepartmentProject & Program Management
Role / Category
Role / CategoryPharma & Biotech Research
Employment type
Employment typeFull Time
Shift
ShiftDay Shift

Job requirements

Experience
ExperienceMin. 5 years

About company

Name
NameAstrazeneca India Private Limited
Job posted by Astrazeneca India Private Limited

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