Associate Lead Data Manager | Novo Nordisk | Bangalore

Job Description

The Position:

The Associate Lead 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 specialized 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 Associate lead Data Manager will be responsible for:

• Participate in 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 oversees the creation of a trial data quality plan (data checks, blinding).
• 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, and Global Safety), as well as timely follow-up. To review/understand data and make operational decisions, use data visualization methods.
• The Associate Lead 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.
• 3-10 Years of experience in the 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.