Job Description

Job Title - Senior Clinical Data Manager IICareer Level - DIntroduction to role:Join us as a Senior Clinical Data Manager II in our Oncology R&D department. In this role, you will be responsible for the coordination of the Clinical Data Management (CDM) deliverables on assigned clinical studies. You will act as a core member of the Global Study Team and lead studies with less complexities. This is an opportunity to collaborate with DM vendors and liaise with a variety of departments on a local and/or global level.Accountabilities:Your role will involve coordinating the Clinical Data Management deliverables on assigned studies, demonstrating leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level. You will be the primary point of contact for DM vendors and provide guidance and supervision to Lead Data Manager/DM Team Lead working on the study. You will also be responsible for compliance to Trial Master File requirements relating to DM Vendor and support Senior Leaders to oversee CDM Vendor performance.Essential Skills/Experience:University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degreeKnowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industryDemonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirementsDemonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC)Demonstrate understanding and experience in query management process and reconciliation activitiesAbility to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.Excellent written and verbal communication skillsAbility to work in a global team environmentExcellent organizational and analytical skills and high attention to detailDesirable Skills/Experience:Demonstrated knowledge of clinical and pharmaceutical drug development processDemonstrated understanding of clinical data system design / development / validation and system interoperability.Demonstrated ability to work effectively with external partnersUnderstanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reportingKnowledge of SQL or SAS softwareExperience leading clinical studies as Data Management LeadWhen 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\xe2\x80\x99s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\xe2\x80\x99re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Why AstraZeneca?Join us on our journey to create the future of medicine as we work towards our ambition to become a healthcare provider beyond medicines. Be part of making the entire Research & Development cycle digitally-enabled: improving clinical trials and data collection, Digital therapeutics for rapid diagnostic, wearables, machine learning and visual analytics for informed decision-making, integrated data to improve patient outcomes, and insights to inform the next generation of products.Are you ready to take your career to the next level? Apply now and join us in our mission to create life-changing medicines!Date Posted 12-Jun-2024Closing Date 15-Jun-2024AstraZeneca 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.

AstraZeneca