Senior Clinical Data Manager II
JOB TITLE: Senior Clinical Data Manager II
CAREER LEVEL: D
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization 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 the role
Responsible for coordination of the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards and technology. May act as a Core member of Global Study Team (GST) and may lead studies with less complexities. Collaborates with DM vendors and liaise with a variety of departments on a local and/or global level to ensure each study is run in accordance to the specifics of the model. Maintains Business Continuity for CDM processes and standards including integrity of the clinical database for the relevant studies. May work under direction of an experienced Principal Project Data Manager.
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 Principle 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.
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 turning point 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 or experience in support of CDM.
Mentoring junior Clinical Data management colleagues
Performs any CDM related ad-hoc requests from Line Manager or superior
Education, Qualifications, and 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 distributed team environment
Excellent organizational and analytical skills and high attention to detail
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
WHY JOIN US?
We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.
We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.
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.
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 authorisation and employment eligibility verification requirements.