Clinical Data Manager II

Job Title: Clinical Data Manager II

Career Level - C

Introduction to role

Support Clinical Data Management (CDM) delivery of high-quality data for assigned medium complex clinical studies or indications that are managed by various Data Management Sourcing Models. Collaborate with DM vendors and liaise with a variety of departments on a local and/or global level to ensure each project is run in accordance with the specifics of the model. Provide solutions to a variety of issues related to CDM administration of moderate scope and complexity whilst adhering to methodology standards. You may work under direction from an experienced Senior Clinical Data Manager or Data Management Delivery Lead.

Accountabilities

Study level CDM administrative 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, KPIs (Key Performance Indicators), and timelines.)
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 regarding upcoming deliverables and milestone achievements (i.e., snapshots, interim, and migrations).
o Oversight of the data quality, documentation quality, and types of these deliverables and milestones.
Responsible for the reporting in CDM specified systems and types of deliverables, milestone achievements, risks and mitigations, and data transfer agreements, and other study administrative needs.
Responsible to meet Quality Compliance requirements.
Oversight of Trial Master File compliance for audit readiness.
Perform User Acceptance Test of internal and external electronic Data Capture systems as required.
Provide support to the resolution of issues related to Clinical Data Management deliverables and inputting ideas to help resolve issues and contribute to continuous improvement.
Perform any CDM related ad-hoc requests from Line Manager or superior.
Mentor junior clinical data management colleagues.
May deputise Data Management Delivery Lead.

Essential Skills/Experience

University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
Clinical Data Management Experience.
Languages: Fluent English (oral and written)
Attention to detail to ensure quality
Good verbal and written skills
Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
Strong interpersonal skills and proven ability to communicate effectively in a global environment

Desirable Skills/Experience

Basic understanding of clinical trials methodology, GCP, and medical terminology
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, 4GL, VBA or R software

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. Thats why we work, on average, a minimum of three days per week from the office. But that doesnt mean were 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 push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. Our pioneering spirit drives us to make bold moves that truly improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry, you will have many opportunities to work with new and novel drugs. We foster a mindset of courage where everyone is empowered to innovate and work at pace. Join us in our mission to make a meaningful difference for patients around the world.

Ready to make a differenceApply now!

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.