16 Aug
|
Novo Nordisk
|
Bengaluru
16 Aug
Novo Nordisk
Bengaluru
Job Title – Senior Data Management Professional
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 clinical trials to the patients who need them.
Your new role
As a Senior Clinical Data Management Professional, you will set the direction and deliver results within your clinical trial(s), ensuring data accuracy, quality, and integrity across the full trial lifecycle. You'll work independently, apply deep subject matter expertise, and play a pivotal role in transforming clinical data into the evidence that supports regulatory submissions and, ultimately, patient access to recent therapies.
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 – from data collection strategy through to database lock and submission deliverables
- Coordinating the CDM&P; trial project plan, including SDTM, ADaM, and TFL deliverables, and aligning priorities with trial goals
- Overseeing DM risk management, including RACT ownership and issue resolution with stakeholders
- Ensuring effective collaboration with CROs and vendors, including oversight of deliverables in the FSO outsourcing model
- Driving compliance with ICH GCP, regulatory requirements, and internal processes while maintaining audit and inspection readiness
- Identifying better-practice opportunities, defining process improvements, and mentoring peers through knowledge sharing in relevant forums
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 t
📌 Senior Clinical Data Management Prof (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru