- The Data ManagerIs accountable for End-to-end trial delivery from DM by project goals, plans, and assigned activities.
- Responsible for DM-related project management and oversight of the end-to-end clinical trial (s) on which they have been assigned at any given time. DM-related project risk identification, issue prevention and resolution, decision facilitation, and management reporting.
- Ensure Clinical data, which meets applicable regulatory requirements, quality, and data standards, is available promptly.
- Ensure setup of clinical data management systems and interfaces. Create, maintain, and execute a Data Management Plan covering all DM activities. Ensure the creation of a data quality plan on a trial (data checks, blinding ..)
- The 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.
- 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) including timely follow-up.
- MSc/BSc in Natural/Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications
- preferably a degree in computer science or equivalent professional experience.
- Preferably 2- 4 years of data management experience the majority of this within Pharma Industry or Development.
- Excellent knowledge of clinical systems used in drug development, in the field of relational database systems,
- Preferably knowledge of clinical development.
- Ability to build and maintain solid internal networks.
- Good communication, presentation, and negotiation skills
- Ability to plan well and handle complex tasks simultaneously and independently.
- Good team player with communication and stakeholder management skills.
- Analytical and result-oriented.
- Proactive and resilient to changes.
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Data Manager - Bengaluru, India - Novo Nordisk A/S
Description
Department –Trial Data Management
Are you experienced in Clinical Data Management? Do you have a strong background in data handling and oversight? We are looking for a Data Management professional to join our team in the Trial Data Management department at Novo Nordisk. If you are ready to take on a challenging role and contribute to the advancement of healthcare, read on, and apply today for a life-changing career.
About the Department
The Trial data management department was established in Bangalore, India in September 2007 and has significantly grown. It is a young, enthusiastic, and dynamic team with varied skills and professionals from diverse backgrounds such as pharmacy, life sciences, physiotherapy, computer/information sciences, and business administration. The key objective of the department is to ensure high-quality data delivery to the stakeholders. The involvement of various groups in data management is significant in key stages of trial setup, conduct, and closeout.
The Position
The Data Manager is expected to serve as Clinical Trial Data Manager (CTDM) within the Trial Squad, your role encompasses a wide range of responsibilities aimed at effectively managing all global data management activities and anticipating new challenges. The CTDM is accountable for project management and end-to-end trial delivery from data management (DM). The Data Manager is expected to fulfill a supporting CTDM role on complex trials and a CTDM PoC role for simpler trials.
The Data Manager Will be responsible for:
Qualification
Working At Novo Nordisk
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 recognize 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, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life-changing.