Senior Clinical Data Manager II

2 weeks ago

Bengaluru, Karnataka, India AstraZeneca Full time

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 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 global team environment

Excellent organizational and analytical skills and high attention to detail

Desirable Skills/Experience:
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

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?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 medicinesDate Posted12-Jun-2024

Closing Date15-Jun-2024

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