Novo Nordisk BSc Life Sciences RBQM Specialist Job Opening, Apply Online
Novo Nordisk BSc Life Sciences RBQM Specialist Job Opening, Apply Online. Life Sciences Jobs. Life Sciences RBQM Specialist Vacancy. Interested and eligible applicants can check out all of the details on the same below
Hey there, looking for assistance on the possible interview questions and answers for the role of RBQM Specialist at Novo Nordisk, then check them below
RBQM Specialist
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
RBQM Specialist
Location- Bangalore
Purpose of the job:
With the purpose of ensuring the right quality and efficiency, being the ambassador of Novo Nordisk RBQM processes and facilitating full adoption and execution across the trial portfolio and phases in all CDC countries via various interactions with different roles such as LoB manager, CDC Trial managers, CRA, CQTM and CDC management.
Key Accountabilities
- Implementation & execution (50%)
- Capability building / Training (30%)
- Effectiveness check (20%)
Main Accountabilities
- Implementation & execution (50%):
- Identify gaps in RBQM implementation and/or execution in CDC and develop projects to address them.
- Represent the CDC in regional and global RBQM networks and actively contribute to improving it.
- Effectively communicate the expectations from the RBQM process within CDC.
- Align the CDC RBQM activities/projects with Global ambitions.
- Actively communicate the benefits of RBQM and set tangible targets for different teams together with the LoB managers and CDC Trial managers.
- Capability building/ Training (30%):
- Provide input to related SOPs, training materials, tools and documents.
- Identify the RBQM training gaps and drive CDC-level training along with regional and CDC CQTMs as required per role.
- Develop a methodology to regularly check the new competencies (skills, ability & knowledge) required within the CDC to accelerate the implementation and execution of RBQM, and communicate those within regional & global networks.
- Ensure the comfort of LoB managers in using RBQM tools, processes, documents and data to improve the right quality and efficiency.
- Effectiveness check (20%)
- Develop CDC-level reports to measure implementation & execution rate, expected improved quality/ efficiencies with the help of RBQM.
- Effectively and regularly communicate the trends and plans with all relevant stakeholders.
Challenges with regard to innovation and change
- The position requires an understanding of ICH/GCP, local clinical trial regulatory requirements and Novo Nordisk SOPs.
- The position holder needs to adapt to changes in the regulatory environment and internal Novo Nordisk procedures as well as help the team to adapt.
- The position requires timely and active communication of issues, queries and progress.
- The position requires knowledge of IT systems such as eTMF, and COSMOS used in the clinical area.
- The position requires a good understanding of risk-based and innovative thinking.
Education requirements: Bachelor’s Degree or higher qualification in Pharmacy, Life Science or another related field.
Work experience
- At least 3 years of clinical trial experience in Clinical Trials at a Sponsor or Clinical Research Organization.
- Strong negotiation skills
- Strong communication skills, verbal and written
- Ability to be independent, multitask and result-oriented with a hands-on attitude in a fast-paced and energetic environment
Hey there, looking for assistance on the possible interview questions and answers for the role of RBQM Specialist at Novo Nordisk, then check them below
- Can you describe your experience in implementing and executing RBQM processes in a clinical trial setting? How have you identified gaps and developed projects to address them?
- Answer: “In my previous role, I played a key role in implementing RBQM processes. I conducted thorough assessments to identify gaps in the execution and developed projects to address them. For example, I initiated initiatives to enhance data quality and streamline monitoring processes. By closely collaborating with cross-functional teams and leveraging RBQM best practices, we successfully improved the overall quality and efficiency of our clinical trials.”
- How have you contributed to capability building and training related to RBQM? Can you provide an example of a training initiative you led?
- Answer: “I actively contributed to capability building and training efforts in RBQM. I assessed training gaps and collaborated with regional and CDC CQTMs to develop comprehensive training programs tailored to different roles. For instance, I led a training initiative to educate trial managers and CRAs on the effective utilization of RBQM tools and processes. By providing hands-on training and continuous support, we ensured that the teams were equipped with the necessary competencies to implement RBQM successfully.”
- How do you measure the effectiveness of RBQM implementation and execution? Can you share an example of a CDC-level report you developed to measure improvements in quality and efficiencies?
- Answer: “To measure the effectiveness of RBQM, I developed CDC-level reports that assessed the implementation and execution rate, as well as the expected improvements in quality and efficiencies. These reports tracked key metrics and trends, such as data completeness, protocol deviations, and site performance. By analyzing the data and presenting it to relevant stakeholders, we were able to identify areas of improvement and implement targeted actions to enhance trial outcomes.”
- How do you adapt to changes in regulatory requirements and internal procedures related to clinical trials? Can you share an example of a situation where you successfully navigated through such changes?
- Answer: “As a professional working in the clinical trial field, I understand the importance of staying updated with regulatory requirements and internal procedures. For instance, when there were updates to ICH/GCP guidelines and Novo Nordisk SOPs, I proactively familiarized myself with the changes and collaborated with the team to ensure compliance. By effectively communicating the updates, clarifying any queries, and supporting the team through the transition, we were able to maintain a high standard of compliance and adapt to the evolving landscape.”
- Can you provide an example of a challenging situation where you applied innovative thinking to overcome obstacles in RBQM? How did your approach contribute to the success of the project?
- Answer: “In a complex clinical trial project, we encountered challenges related to data quality and monitoring processes. To address these issues, I applied innovative thinking by leveraging technology and automation solutions. For instance, I introduced risk-based monitoring approaches that utilized advanced data analytics to identify critical data points and potential risks. By adopting these innovative strategies, we were able to optimize monitoring efforts, improve data quality, and ensure efficient trial management, ultimately leading to successful outcomes.”
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