Senior Clinical Data Manager II

Are you ready to coordinate Clinical Data Management deliverables on pivotal clinical studies? As a Senior Clinical Data Manager II, you'll be at the forefront of ensuring the integrity and continuity of our clinical databases. Collaborate with diverse teams and vendors globally to drive studies in line with our innovative models. Whether you're leading less complex studies or acting as a core member of the Global Study Team, your expertise in CDM processes, standards, and technology will be crucial. Dive into a role where your leadership and operational knowledge will shine, all while working under the guidance of a Project Data Manager.

Accountabilities:
Coordinate the Clinical Data Management deliverables on assigned studies depending on the relevant model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
• Demonstrates leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level potentially under mentorship from a Project Data Manager.
• Communicates and collaborates effectively with all study team members. Primary point of contact for DM vendor and provides guidance and supervision to Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
• Oversight of day-to-day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk. Escalates issues/risks when necessary.
• Understands corporate, therapeutic/indication or program specific data capture AZ standards.
• Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.
• Responsible for compliance to Trial Master File requirements relating to DM Vendor.
• Support Senior Leaders to oversee CDM Vendor performance, depending on relevant model. Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance. Oversees vendor timelines and milestone deliverables for the assigned studies. Ensures DM Vendor billing is accurate and gives recommendations for payment of invoices.
• Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies.
• Demonstrates willingness to take on ad-hoc activities consistent with current CDM work experience.
• Ensures relevant training is completed prior to performing tasks.
• Mentoring junior Clinical Data Management colleagues.
• Performs CDM related ad-hoc requests from Line Manager.

Essential Skills/Experience:
• University or college degree in the 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 of clinical databases, different clinical data management systems and electronic data capture (EDC)
• Demonstrate understanding and experience in query management process and reconciliation activities
• Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines
• Excellent written and verbal communication skills
• Ability to work in a global team environment
• Excellent organizational and analytical skills and high attention to detail

Desirable Skills/Experience:
• Demonstrated knowledge of clinical and pharmaceutical drug development process
• Demonstrated understanding of clinical data system design / development / validation and system interoperability
• Demonstrated 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, curiosity meets courage as we explore new scientific horizons. Our inclusive environment fosters collaboration across academia, biotech, and industry, empowering us to make swift impacts on disease. With a commitment to advancing healthcare globally, we leverage digital innovation to pioneer breakthroughs that redefine possibilities. Here, every voice is heard, every idea valued, as we unite diverse minds to deliver life-changing medicines.

Ready to make a difference? Apply now and join us on this exciting journey!

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.