Senior Clinical Data Manager I

Job Title: Senior Clinical Data Manager I

Introduction to role:

Are you ready to dive into the world of Clinical Data Management and make a significant impact on global health? As a Senior Clinical Data Manager I, you'll play a crucial role in coordinating CDM deliverables for assigned clinical studies. You'll be an expert in CDM processes, standards, and technology, collaborating with DM vendors and liaising with various departments to ensure seamless study execution. Your work will maintain the integrity of clinical databases and uphold business continuity for CDM processes and standards. If you're eager to contribute to groundbreaking studies and work alongside experienced professionals, this role is for you!

Accountabilities:

In this dynamic position, 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 deliverables at a study level, reporting study status to clinical teams, collaborating with Data Management Vendors, and overseeing data quality. Additionally, you'll assist in coordinating CDM deliverables on assigned projects, identify risks, and collaborate with Study Data Managers to mitigate them. Your expertise will extend to understanding therapeutic area-specific data capture standards and providing input into regulatory inspections/audits. You'll also mentor junior colleagues and perform ad-hoc requests from your Line Manager.

Essential Skills/Experience:

- University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
- End to end 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 leading studies, 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.
- Knowledge of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.
- Demonstrated understanding of clinical data system design / development / validation and system interoperability.
- Demonstrated ability to work effectively with external partners.
- Knowledge of SQL, 4GL, VBA or R Programming.

At AstraZeneca, we are driven by our passion for science and our commitment to making a difference in patients' lives. Our innovative approach combines data and technology with scientific breakthroughs to tackle some of the world's most complex diseases. We foster an environment where curiosity thrives, empowering our teams to explore new possibilities without fear of failure. By collaborating with academia, biotechs, and industry leaders, we leverage diverse knowledge to create impactful solutions. Join us in our mission to redefine healthcare and improve patient access globally.

Ready to take the next step in your career? Apply now to become part of our transformative 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.