Associate Monitoring System Specialist

Associate Monitoring System Specialist

Are you passionate about system monitoring specialist? Do you have the expertise to drive innovation and ensure compliance with evolving FDA requirements? If so, we invite you to join our Associate Monitoring System Specialist in Bangalore. Apply today for a life-changing career.

The Centralised Monitoring Unit (CMU) in Bangalore is part of the Clinical Drug Development area. Our team is a perfect blend of skilled medical professionals and technical programmers. Medical reviewers focus on ensuring patient safety and compliance, while Functional Programmers develop operational visualisations to support trial teams. Statistical Monitors detect unusual data patterns and potential compliance issues across trials. Our collaborative environment ensures the highest standards of clinical trial monitoring and data integrity.

As an Associate Monitoring System Specialist at Novo Nordisk, you will play a key role in providing expert knowledge and technical support for Trial, Statistical, Central, and Medical Monitoring. Acting as a subject matter expert, you will mentor team members on systems and documentation practices, ensure system maintenance and quality, and assist in issue resolution. You will support CMU by managing monitoring deliverables, optimizing processes through collaboration, and ensuring consistency for audits and inspections. Additionally, you'll contribute to onboarding new employees, maintaining training materials, and implementing new systems and tools.

• Lead improvement projects within the CMU/RBQM office, driving the implementation of new processes.
• Provide solution-oriented insights to enhance systems and processes, conducting independent explorations to improve standard content.
• Ensure alignment and collaboration with other key areas for seamless RBQM process integration.
• Act as an ambassador for CMU, promoting better practices and the use of standards across systems, processes, and roles.
• Collaborate with Data Management, Biostatistics, and Programming teams, sharing learnings and advising peers and consultants on documentation and standards implementation.

• M.Sc / B.Sc in Life Science, Computer Science, Information Technology, or a related field.
• 8-10 years of experience in the pharmaceutical industry, with 5-6 years in clinical data management systems.
• Expertise in SAS programming, JSL, SQL/PLSQL, and VBScript.
• Proficiency with BI tools such as Qlik Sense, Sisense, and Power BI.
• Extensive experience with clinical systems and interfaces.
• Deep knowledge of GxP regulations and drug development guidelines.
• Strong skills in data analytics, mathematics, and statistical concepts.
• Excellent communication and presentation abilities, with experience in global and cross-cultural environments.

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, were working toward something bigger than ourselves, and its a collective effort. Join us Together, we go further. Together, were life changing.

To submit your application, please upload your CV online (click on Apply and follow the instructions).

28th Oct 2024.

Disclaimer
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, were life changing.

Locations - Bangalore, Karnataka, IN