Principal Clinical Data Lead

Are you ready to lead clinical data strategy that accelerates therapies for patients with rare diseases? Do you thrive at the intersection of scientific rigor, innovation, and multi-functional coordination where high-quality data drives pivotal decisions?

As the senior lead for clinical data, you will develop the processes for collecting, curating, and unlocking clinical data. This applies to sophisticated, global studies. You will partner across development, biostatistics, clinical operations, and safety to deliver credible, inspection-ready evidence that advances our pipeline and reaches under-served patient populations sooner. Your leadership will elevate vendor performance, modernize data collection, and ensure every database locks with confidence—so patients and caregivers can benefit from our medicines faster.

Accountabilities:

• Data Strategy and Build: Define study data strategies, standards, and solutions that align with protocol objectives, endpoints, and regulatory expectations, ensuring data supports crucial analyses and submissions.
• Study Start-up Leadership: Own the building of data collection instruments, development of data validation rules, completion guidelines, and user acceptance testing; take ownership of the data handling strategy and drive process improvements to reduce cycle time and errors.
• Data Quality and Integrity: Lead validation for sophisticated studies, set quality metrics, and implement risk-based approaches that proactively detect and resolve issues to protect data credibility.
• Vendor and Partner Oversight: Provide technical direction and governance to CROs, FSPs, and data vendors. Ensure your work meets scope, quality, and timelines, raising issues and adjusting plans when needed.
• Operational Excellence: Orchestrate ongoing data operations across external data transfers, specifications, agreements governing the import and export of data, database migrations, ad-hoc reporting, coding activities, lock and archiving—keeping studies on track.
• Introduce and evaluate new methods for data capture. Include supplementary information sources outside the organization. Promote innovation that improves data completeness, patient experience, and study efficiency.
• Compliance and Preparation for Inspections: Ensure medical coding, reporting, drug supply interfaces, collaborative platforms, and third-party data functions follow quality standards and are audit-ready.
• Establish and monitor delivery plans, important metrics, and status across studies. Anticipate risks, remove blockers, and improve data management workflows for faster, reliable outcomes.

Essential Skills/Experience:

• Collaborating with peers across the data governance function and throughout the organization to identify, develop and deliver appropriate data management solutions.
• Providing technical expertise and completing data management tasks. Leading work from CROs, FSPs, and vendors to ensure timely completion.
• Innovating data collection methods and ensuring the development and delivery of medicines for our patients using strategic thinking, strong collaboration and communication skills, and an entrepreneurial mindset.
• Leading or coordinating study-specific study start-up tasks, including case report form (CRF) build, edit check creation, CRF completion guideline (CCG) creation, and validation by end users including leading process improvements and enhancements, as needed. Leading the development and maintenance of the data management plan (DMP).
• Leading data validation tasks for complex studies during maintenance and close-out, focusing on data integrity and quality metrics.
• Leading ongoing operational support for all activities during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock, archiving, and clinical coding activities.
• Ensuring all quality and compliance activities are complete, including medical coding, report generation, drug supply, other database integrations, and external data activities.
• Independently monitoring activities and project status for successful project deliverables according to the timeline while participating in initiatives to streamline data management processes.

Desirable Skills/Experience:

• Deep knowledge of EDC platforms and clinical data technologies (e.g., Medidata Rave, InForm, eCOA/ePRO, IxRS/IRT) with hands-on configuration experience.
• Mastery of data standards and regulations (e.g., CDISC SDTM/CDASH, controlled terminology, ICH E6(R2)/E6(R3), 21 CFR Part 11, GDPR) and inspection readiness.
• Experience with external and real-world data sources, lab data harmonization, imaging, genomics, or wearable/device data integrations.
• Proficiency in data review automation, analytics, and visualization tools (e.g., SAS, SQL, Python/R, Spotfire, Power BI) to accelerate insight generation.
• Proven leadership in rare disease or small, complex patient populations; comfort with adaptive designs and evolving evidence needs.
• Strong vendor governance, contract oversight, and risk management capabilities across multi-country, multi-vendor trials.
• Effective communication and influence skills to align clinical, biostatistics, safety, and operational teams around data-driven decisions.

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/Alexion:

Here, patient impact is the north star and data is the engine. You will join a collaborative, kind, and ambitious community that combines the agility of a biotech with the scale and scientific depth of a global biopharma.

We put unexpected teams together to spark bold ideas, invest in cutting-edge data capabilities, and empower leaders to grow with tailored development and genuine support.

Your contribution will directly shape the evidence behind therapies for people with rare and devastating conditions, turning rigorous data into meaningful change—while we value kindness alongside ambition and celebrate diverse perspectives that lead to better science.

Call to Action:

Bring your leadership to where data changes lives—step forward today and help us deliver trusted evidence faster for patients who need it most!

#LI-Hybrid

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Annual base salary for this position ranges from 131,520.80 to 172,621.05.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.