Senior Clinical Data Manager

Job Title: Senior Clinical Data Manager

Career Level – D

Introduction to Role:

Are you ready to take the next step in your career and make a significant impact in the field of Oncology? We are seeking a Senior Clinical Data Manager II to join our Oncology R&D team. This role is responsible for coordinating the Clinical Data Management (CDM) deliverables on assigned clinical studies. You will be a core member of our Global Study Team and may lead studies with less complexities. This is an opportunity to learn and grow from the brightest minds in the industry and truly make a difference in the lives of patients living with cancer.

Accountabilities:
As a Senior Clinical Data Manager II, you will coordinate the Clinical Data Management deliverables on assigned studies, serve as the first line of contact at the study level, and demonstrate leadership in planning and delivering CDM deliverables. You will be responsible for overseeing day-to-day operational aspects of CDM for assigned studies, identifying risks, and collaborating with the DM Vendor to mitigate these risks. You will also provide input into CDM related activities associated with regulatory inspections/audits for assigned studies and ensure compliance to Trial Master File requirements relating to DM Vendor.

Essential Skills/Experience:
– University or college degree in 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
– Experience with clinical databases, different clinical data management systems and electronic data capture (EDC)
– 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 global team environment
– Excellent organizational and analytical skills and high attention to detail

– Knowledge of clinical and pharmaceutical drug development process
– Understanding of clinical data system design / development / validation and system interoperability
– 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
– Experience leading clinical studies as Data Management Lead

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. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re 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?
At AstraZeneca, we are united in our vision to eliminate cancer as a cause of death. We are pioneers, making bold moves that transform the way cancer is treated and truly improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next. We foster a mindset of courage, where everyone is empowered to step up, innovate, and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It’s science with an impact-making a difference for patients and people around the world.

Ready to make your mark? Apply now!

Date Posted

07-Oct-2024

Closing Date

12-Oct-2024

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.