Senior Clinical Data Manager II

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Job Title: Senior Clinical Data Manager II

Introduction to role:

Are you ready to lead the charge in Clinical Data Management? As a Senior Clinical Data Manager II, you'll coordinate CDM deliverables on assigned clinical studies, acting as a core member of the Global Study Team. Your expertise in CDM processes, standards, and technology will be crucial as you collaborate with DM vendors and liaise across departments globally. You'll ensure the integrity of clinical databases and maintain business continuity for CDM processes and standards. Ready to make a difference?

Accountabilities:

Take charge of coordinating Clinical Data Management deliverables on assigned studies, serving as the primary contact at the study level.

• Exhibit leadership and operational knowledge in planning and delivering CDM deliverables, potentially under mentorship from a Project Data Manager.
• Communicate and collaborate effectively with study team members, guiding and supervising Lead Data Managers/DM Team Leads.
• Oversee day-to-day operational aspects of CDM, identifying risks and collaborating with DM Vendors to mitigate them.
• Understand corporate, therapeutic/indication, or program-specific data capture standards.
• Provide input into CDM activities related to regulatory inspections/audits for assigned studies.
• Ensure compliance with Trial Master File requirements related to DM Vendors.
• Support senior leaders in overseeing CDM Vendor performance, reviewing delivery against KPIs, budget, and overall performance.
• Drive adherence to AZ CDM standards for data quality and consistency.
• Mentor junior Clinical Data Management colleagues and perform ad-hoc requests from Line Manager.

Essential Skills/Experience:

• University or college degree in life sciences or related subject, pharmacy, nursing, or equivalent relevant degree
• Knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry
• Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
• Demonstrated experience with clinical databases, different clinical data management systems, and electronic data capture (EDC)
• Understanding and experience in query management process and reconciliation activities
• Ability to work flexibly on simultaneous projects and proactively manage time to meet deadlines
• Excellent written and verbal communication skills
• Ability to work in a global team environment
• Excellent organizational and analytical skills with high attention to detail

Desirable Skills/Experience:

• Demonstrated knowledge of clinical and pharmaceutical drug development process
• Understanding of clinical data system design/development/validation and system interoperability
• Ability to work effectively with external partners
• Understanding of database structures, programming languages, data standards (CDISC), and practices as they apply to CRF design, database development, data handling, and reporting
• Knowledge of SQL or SAS software
• Experience leading clinical studies as Data Management Lead

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, we are driven by curiosity and courage to explore what science can achieve. Our commitment to making a difference is evident as we fuse data and technology with scientific innovation to tackle some of the world's most complex diseases. We embrace lifelong learning and offer varied opportunities for growth, whether working at the leading-edge or on diverse stages and molecules. Here, you can build a meaningful career while contributing to breakthroughs that impact patients globally.

Ready to take the next step in your career? Apply now and join us in pushing the boundaries of science!

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.