Novo Nordisk is Hiring M.Sc. / B.Sc Life Science For Senior Data Manager Position
Novo Nordisk is a Danish multinational pharmaceutical company. Novo Nordisk is Hiring M.Sc. / B.Sc Life Science For Senior Data Manager Position. Interested Candidates check out the details below and Apply Online.
Job title: Senior Data Manager
Job Location: Bangalore, India
Job Category: Clinical Development and Medical
Job Type: Full Time
Last Date to Apply: 20th September 2023
Job Position
The Senior Data Manager is expected to serve as a CTDM point of contact for complex trials (including new data sources) or across multiple trials. Alternatively, being specialised in a business-critical process or system and capable of applying this expertise across multiple trials. Mentor more junior colleagues and contribute with an innovative mindset that challenges the status quo. The Senior Data Manager will be responsible for:
- Participate and provide input to protocol outline and protocol development. Define the structure and specifications for data collection in collaboration with internal and external stakeholders (CRF, external data).
- Supervise the setup of clinical data management systems and interfaces. Create, maintain, and put into action a Data Management Plan that covers all data management activities and oversee the creation of a trial data quality plan (data checks, blinding).
- DM related activities are in compliance with all existing applicable internal and requirements team spirit within the team of CTDs, whenever more CTDMs are allocated to a trial.
- Ensure clear and concise communication with operational and functional trial partners (e.g., Data Management Systems and Standards, Biostatistics, Trial Operations, Medical & Science, Clinical Supplies, Global Safety), as well as timely follow-up. To review / understand data and make operational decisions, use data visualisation methods.
- The Senior Data Manager will perform post- Database Lock (DBL) activities to ensure submission-ready data and resolve or escalate major issues, with assistance from the Manager of the relevant data management unit.
Qualifications
- M.Sc. /B.Sc. in Natural/Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications. A degree in computer science or equivalent professional experience.
- 4-10 Years of experience in pharmaceutical or development industry and preferably with an end-to-end exposure in Clinical Data Management.
- Excellent knowledge of clinical systems used in drug development, in the field of relational database systems.
- Experience working under quality requirements such as GCP and ISO, Clinical development, and Project Management.
- Excellent written and spoken English.
- Ability to plan well and handle complex tasks simultaneously and independently.
Analytical and result oriented. - Good team player with communication and stakeholder management skills.
Proactive and resilient to changes.
Novo Nordisk is Hiring M.Sc. / B.Sc Life Science For Senior Data Manager Position. Here are five interview questions along with their answers:
Question 1: Can you describe your experience in overseeing the setup of clinical data management systems and interfaces?
Answer: Certainly. In my previous role as a Senior Data Manager, I have been responsible for supervising the setup of clinical data management systems and interfaces for various trials. This involved collaborating with cross-functional teams to ensure seamless integration and compatibility between different data sources. I have experience in defining data specifications, overseeing the creation of Data Management Plans, and ensuring trial data quality through appropriate checks and blinding procedures. My role also included maintaining clear communication with operational and functional partners to ensure a streamlined data management process.
Question 2: How do you ensure compliance with quality requirements such as GCP and ISO during clinical data management activities?
Answer: Ensuring compliance with quality requirements is crucial in clinical data management. I make sure to stay updated with current GCP and ISO guidelines and regulations. Throughout my career, I’ve developed and implemented processes and protocols that align with these standards. This includes conducting regular quality checks, data validation, and maintaining proper documentation of all data management activities. I also actively participate in internal and external audits to ensure that our practices meet or exceed industry standards.
Question 3: Could you provide an example of a challenging trial you’ve worked on and how you managed the complexities of data management within that trial?
Answer: Certainly. In a recent complex trial involving new data sources, my role as a Senior Data Manager was to ensure efficient data collection, integration, and quality. The trial required data from various sources, including external partners. I collaborated closely with both internal and external stakeholders to define data collection specifications and develop a robust Data Management Plan. By employing effective data visualization techniques, I was able to identify potential issues early and make operational decisions promptly. This proactive approach helped maintain data quality and streamline the trial’s progress.
Question 4: How do you approach mentoring junior colleagues and fostering a collaborative team spirit within the Clinical Trial Data Management (CTDM) team?
Answer: Mentoring junior colleagues is a vital aspect of my role. I believe in creating a supportive and collaborative environment within the CTDM team. I regularly conduct knowledge-sharing sessions to impart best practices and share insights from my experience. I encourage open communication, where team members can ask questions and seek guidance without hesitation. By fostering a culture of continuous learning and mutual support, I ensure that the team collectively grows in expertise and efficiency, ultimately contributing to the success of our trials.
Question 5: Can you provide an example of a situation where you had to handle post-Database Lock (DBL) activities to ensure submission-ready data and resolve major issues?
Answer: Certainly. In a recent trial, after the Database Lock, we encountered unexpected discrepancies in the trial data. As the Senior Data Manager, I led the investigation to identify the root causes of these discrepancies. I collaborated with the relevant teams, including Biostatistics and Trial Operations, to devise a corrective action plan. Through meticulous data analysis and collaboration, we were able to resolve the issues and ensure that the data was submission-ready within the required timeline. This experience showcased my ability to handle high-pressure situations, collaborate effectively, and take decisive actions to maintain data integrity. Novo Nordisk is Hiring
