JOB TITLE: PRINCIPAL STUDY DATA MANAGER

CAREER LEVEL: E1

Leverage technology to impact patients and ultimately save lives

Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that

focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.

ABOUT OUR IT TEAM

It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.

ABOUT THE ROLE

• 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 results at a study level potentially under mentorship from a Principle Clinical Project Data Manager.
• Communicates and collaborates effectively with all study level 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 the day to day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor 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 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 landmark
• 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.
• Maintain an awareness of the external and internal models in order to participate in change initiatives and continuous
• improvement activities 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

ESSENTIAL SKILLS REQUIRED

• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
• Solid 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
• Good communication and interpersonal skills including effective problem solving
• Ability to work independently without close supervision
• Excellent written and verbal communication skills
• Ability to work in a distributed team environment
• Excellent organizational and analytical skills and high attention to detail

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

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.