Senior Clinical Data Manager I (EDO)

Job Title: Senior Clinical Data Manager I (EDO)

Introduction to role:

Are you ready to dive into the world of clinical data management and make a difference? As a Senior Clinical Data Manager I, you'll play a pivotal role in coordinating Clinical Data Management (CDM) results for assigned clinical studies. You'll be a guide in CDM processes, standards, and technology, collaborating with DM vendors and liaising with various departments to ensure each study runs smoothly. Your work will maintain the integrity of clinical databases and support business continuity for CDM processes and standards. Join us and be part of a team that is committed to advancing healthcare!

Accountabilities:

In this role, you'll provide study-level CDM operational support based on the relevant model and DM Vendor. Your responsibilities will span across study start-up, conduct, and closeout phases, including documentation review, user access testing, query management, data cleaning, and third-party data reconciliation. You'll demonstrate leadership in planning and delivering CDM results at a study level, reporting study status to clinical study team members, collaborating with Data Management Vendors, and being responsible for data quality. You'll also assist in coordinating CDM results on assigned projects, identify risks, and collaborate with the Study Data Manager to mitigate them. Your expertise will contribute to regulatory inspections/audits and compliance with Trial Master File requirements. You'll drive adherence to AZ CDM standards and processes, flagging opportunities for continuous improvement. Mentoring junior colleagues and performing ad-hoc requests from your Line Manager will also be part of your dynamic role.

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 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 o 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.) o 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:

• 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 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 o 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.) o Collaboration with Data Management Vendor/Study Data Manager regarding upcoming results and breakthrough achievements (i.e., snapshots, interim, and migrations).
• Oversight of the data quality, documentation quality, and types of these deliverables and breakthroughs.
• 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

When we put unexpected teams in the same room, we ignite 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, we are driven by curiosity and courage as we explore new scientific frontiers. Our commitment to making a difference fuels our passion for science as we fuse data technology with innovation. We work seamlessly as one inclusive team alongside academia, biotechs, and industry partners. Here you'll find opportunities for lifelong learning as we push boundaries to deliver life-changing medicines.

Ready to make an impact? Apply now!

Date Posted

06-Oct-2025

Closing Date

08-Oct-2025

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.

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 authorisation and employment eligibility verification requirements.