Principal Clinical Data Platforms Lead

Are you ready to make a significant impact in the world of rare diseases? As a Principal Clinical Data Platforms Lead, your role includes developing strategy and carrying out execution for Electronic Data Capture (EDC) and clinical data management technologies. With a solid focus on the Medidata platform, you'll ensure compliant delivery of study data management systems from start-up through closeout. Collaborate with internal team members and external vendors, drive platform and process innovation, and provide technical leadership for EDC programming delivery on studies. Your expertise will help define guidelines and operational processes that support efficient clinical study execution.

Accountabilities

• Medidata Expertise: Provide hands-on technical and programming support across Medidata Platform (Rave, Coder, Safety Gateway, tSDV, Cloud Admin, eCOA/Patient Cloud, RWS) and guide platform use from study start-up through closure.
• rCDI Platform Governance & Compliance: Develop and implement strategies for rCDI systems oversight, ensuring alignment with GxP, 21 CFR Part 11, Annex 11, and privacy requirements.
• Platform Delivery & Oversight: Coordinate configuration, integrations, change control, vendor/CRO management, and maintain system inventory, validation, and data flows.
• Process, Standards & Validation: Define guidelines, lead upgrades and new functionality validation, conducts periodic reviews, and lead feature onboarding across rCDI platforms.
• Platforms Training, Innovation & Collaborator Engagement: Drive user training and adoption, pilot new technologies, scale improvements, and communicate complex topics to senior leaders while supporting audits and CAPAs.

Essential Skills/Experience

• Bachelor’s degree or equivalent experience with proven ability working with clinical trial technologies and supporting GxP platform compliance.
• Medidata platform knowledge ideally including Rave, Coder, Rave Safety Gateway, tSDV, Cloud Admin, eCOA/Patient Cloud and RWS. Additional Module knowledge would be an advantage.
• Ability to define and lead platform improvement, innovation projects and interact with internal and external collaborators at senior levels of management.
• Superb communication skills in both written and spoken English with an ability to interpret and communicate technical information into business language.
• High proficiency with technology associated with current and evolving data management practices.
• Solid ability to solve complex, abstract problems in cross-functional business collaboration and independent projects while demonstrating proactive drive, sound decision-making, and attention to detail.

Desirable Skills/Experience

• Solid understanding of emerging, innovative technologies in clinical trial data management.
• Experience of working in a global organization with sophisticated/geographical context.
• Experience of agile working practices and a good understanding of project management techniques and methods.
• Knowledge of the end-to-end clinical trial process.
• Extensive technical/industry experience.

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.

At AstraZeneca, you'll find an environment where innovation thrives. Our commitment to rare diseases means we're at the cutting edge of biomedical science. With resources and global reach, we push boundaries to translate complex biology into transformative medicines. Our culture is rooted in integrity and inclusiveness, empowering you to make a real difference in patients' lives. Join us to explore new ideas and grow your career in a supportive community.

Ready to take the next step? Apply now to join our team!

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.