Senior Clinical Data Manager I

Job Title: Senior Clinical Data Manager I

Introduction to role:

Are you ready to turn sophisticated study data into trusted evidence that accelerates decision-making and advances medicines to patients? In this role, you will lead study-level clinical data management, partnering with study teams and vendors to deliver clean, consistent, analysis-ready datasets that drive faster, more confident outcomes.

You will sit at the heart of pivotal studies, shaping how data is captured and curated from start-up through closeout. Can you see yourself orchestrating in-stream reviews, third-party data reconciliation, and risk mitigation to keep achievements on track? Your expertise will directly influence how quickly promising therapies move through development, with measurable impact on patients and the business.

Accountabilities:

• Study Start-Up and Design Governance: Establish and document the study data management approach; plan and test user access; set up query workflows and data cleaning strategies to enable reliable data from day one.
• Data Quality Oversight: Lead in-stream data review, lab data review coordination, and third-party data reconciliation to assure completeness, accuracy, and consistency across sources.
• Vendor Partnership and Achievement Management: Collaborate with Data Management Vendors and the Study Data Manager to plan snapshots, interim deliveries, and migrations; scrutinize result quality and documentation to meet study needs.
• Risk Management and Issue Resolution: Identify daily operational risks in CDM and partner with the Study Data Manager to mitigate, ensuring timelines and indicators remain achievable.
• critical metric and Timeline Stewardship: Track and report study status to clinical teams; provide data to support medical and clinical reviews; hold teams accountable to agreed indicators and project timelines.
• Regulatory Readiness: Contribute to audit and inspection preparation for assigned studies; ensure data management activities and records meet regulatory expectations.
• Standards Stewardship: Apply therapeutic area and program-specific data capture standards alongside internal standards to drive consistency and reusability.
• Systems and Vendor Input: Provide informed input on the selection and use of software systems, devices, and vendors to best fit study needs and operating models.
• TMF Compliance: Ensure Trial Master File requirements are met for data management vendor records and documentation.
• Continuous Improvement: Supervise internal and external operating models; flag opportunities to streamline processes, enhance quality, and improve vendor performance.
• Mentorship and Team Contribution: Coach junior clinical data management colleagues; take on ad hoc activities aligned to expertise to support delivery across the portfolio.

Essential Skills/Experience:

• Study level CDM operational support based on the relevant model and DM Vendor. This may include but is not limited to activities related to the study start up, conduct and closeout phases. (i.e., Documentation review and/or creation, User Access Testing, query management, data cleaning and reviews, third party data reconciliation in accordance with the project study model, critical metrics (Key Performance Indicators) and project timelines.)
• Demonstrates leadership and operational knowledge in the planning and delivery of CDM results at a study level.
• Day to day responsibilities may include but are not limited to:
• Study status reporting to the relevant clinical study team members, (e.g., provide data to clinical teams for performing medical and clinical reviews, coordination of instream data review, lab data review, etc.)
• Collaboration with Data Management Vendor/Study Data Manager regarding upcoming results and achievements (i.e., snapshots, interim, and migrations).
• Oversight of the data quality, documentation quality, and types of these results and achievements.
• Assist with coordination in the Clinical Data management results on assigned projects depending on the relevant model and DM Vendor.
• Oversight of the day-to-day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the Study Data Manager to mitigate the risk.
• Understands therapeutic area, indication or program specific data capture standards and AZ standards.
• Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.
• May provide input to the selection and use of software systems, devices, and vendors.
• Responsible for compliance with Trial Master File requirements relating to DM Vendor.
• Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies.
• Maintain an awareness of the external and internal models in order to flag for continuous improvement related to CDM operating models.
• Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.
• Mentoring junior Clinical Data management colleagues
• Performs CDM related ad-hoc requests from Line Manager

Desirable Skills/Experience:

• Proven expertise with leading EDC and clinical data platforms, including planning and completing User Access Testing.
• Hands-on experience with third-party data sources such as central labs, imaging, and connected devices, and with in-stream data review strategies.
• Familiarity with clinical data standards and models such as CDISC, SDTM, ADaM, and controlled terminology.
• Experience supporting audits and inspections, including authoring and reviewing data management documentation.
• Demonstrated ability to improve CDM operating models, indicators, and vendor performance through metrics and continuous improvement.
• Strong communication and collaboration skills to engage cross-functional collaborators and influence vendor outcomes.
• Exposure to complex study designs, migrations, interim analyses, or program-level data flows.

When we put unexpected teams in the same room, we fuel 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:

You will join a research and development organization that fuses scientific curiosity with digital, data science, and AI to unlock breakthroughs faster, bringing therapies for complex diseases to those who need them most. We put unexpected teams in the same room to challenge assumptions, learn from real patient experiences, and turn ideas into tangible progress, backed by the resources and pace of a leading global company. Here, ambition is matched with kindness and support; your leadership in clinical data will shape study outcomes, sharpen decisions, and contribute to medicines that can touch millions of lives.

Call to Action:

If you are ready to lead study-level data quality and convert complexity into clarity that speeds promising medicines forward, take the next step and share your story with us today!

Date Posted

Closing Date

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.