Senior Clinical Data Management Prof Professional
Novo Nordisk · Bengaluru, Karnataka, India
Novo Nordisk · Bengaluru, Karnataka, India
**Job Title** Senior Data Management Professional **Company** Global Business Services, India **Department** Clinical Data Management & programming **Location** Bangalore Shape the data behind tomorrows 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. Youll 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 new 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, youll 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, you will join Clinical Data Management & Programming (CDM&P), the team responsible for ensuring the integrity and quality of clinical trial data that underpins every submission we make. Working across therapeutic areas and in close collaboration with statisticians, medical scientists, clinical reporting, and global trial operations, youll be part of a team that connects rigorous data stewardship directly to patient outcomes. The daily work is performed from your local base, collaborating with colleagues, stakeholders, and projects globally. **Your skills & qualifications** Were looking for a Senior Clinical Data Management Professional who thrives on complexity and takes pride in delivering high-quality results in a dynamic, international environment. Youll bring with you: - An MSc or BSc in IT, Natural or Life Sciences, or equivalent - 3+ years of experience working within clinical data management or equivalent, with a good understanding of DM processes, clinical data flow, GCP, and regulatory requirements - Experience leading trials or projects in an international setting with increasing complexity - Strong analytical and data literacy skills, combined with excellent project management and coordination abilities - A self-driven, results-oriented working style with the ability to handle multiple tasks simultaneously and manage a variable workload - Open, constructive communication and negotiation skills, with the ability to relate to colleagues in a multinational environment - Fluency in written and spoken English Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.