17 Aug
|
Novo Nordisk
|
Bengaluru
17 Aug
Novo Nordisk
Bengaluru
Job Title – Associate Senior Clinical Data Management Qualified
Company – Global Business Services, India
Department – Clinical Data Management & programming
Location – Bangalore
Shape the data behind tomorrow's treatments – and help bring life-changing therapies from trial to patient, faster.
Your new role
As an Associate Senior Clinical Data Management Qualified, you will take ownership of data management deliverables across clinical trials, ensuring the accuracy, quality, and integrity of the data that underpins our pipeline. You will lead trial-level data management activities from collection through to submission, coordinating across functions and driving operational excellence in a dynamic, global setting.
Your key responsibilities will include:
Leading the data management trial team, acting as the DM point of contact and co-chairing the Trial Squad
Planning, executing, and delivering all DM trial activities, including the CDM&P; trial project plan and coordinating SDTM, ADaM, and TFL deliverables
Defining the data collection strategy aligned with protocol and standards, and managing associated risks
Overseeing DM risk management, including RACT and issue resolution across the trial lifecycle
Ensuring effective collaboration with CROs and vendors, including oversight of deliverables in the FSO outsourcing model
Optimising trial design through protocol input and maintaining DM plans and key documents
Supporting compliance with ICH GCP, regulatory requirements, and internal processes, while ensuring audit and inspection readiness
Your new department
In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.
Within R&D;, the Clinical Data Management & Programmi
📌 Assoc Sr Clinical Data Management Prof Bengaluru
🏢 Novo Nordisk
📍 Bengaluru