The Clinical Trial Data Manager is entrusted with serving as the Clinical Trial Data Manager (CTDM) within our Trial Squad. This role involves a broad spectrum of responsibilities to manage all global data management activities efficiently and proactively anticipate new challenges. Additionally, the Clinical Trial Data Manager is accountable for project management and ensuring end-to-end trial delivery from data management (DM). On complex trials, the Clinical Trial Data Manager is expected to fill a supporting CTDM role while also taking on the CTDM Point of Contact (PoC) role for simpler trials.
As a Clinical Trial Data Manager at Novo Nordisk, you will have the opportunity to:
- Responsible for CDM-related project management and oversight of the end-to-end clinical trial (s) on which they have been assigned at any given time. CDM-related project risk identification, issue prevention and resolution, decision facilitation, and management reporting.
- Be accountable for end-to-end trial delivery from data management, ensuring project goals, plans, and assigned activities are met.
- Manage and oversee the entire clinical trial, identifying and addressing project risks, facilitating decision-making, and providing management reporting.
- Ensure the availability of clinical data that meets regulatory requirements, quality standards, and data standards.
- Set up clinical data management systems and interfaces, create and execute a Data Management Plan, and establish a data quality plan for each trial.
- Perform post-database lock activities to ensure submission-ready data and resolve any major issues. Maintain clear and concise communication with operational and functional trial partners.
Qualifications
- MSc/BSc in Natural/Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications
- Preferably 2- 4 years of data management experience the majority of this within the Pharma Industry or Development.
- Excellent knowledge of clinical systems used in drug development, in the field of relational database systems.
- Strong knowledge and experience in data systems management, data analysis and review, and data quality and integrity assurance.
- Proficiency in data acquisition, transformation, and harmonization, as well as regulatory submission package input.
- Familiarity with data management and data analytics tools, trial regulations and legislation, and data governance and security.
- Understanding of data architecture and business communication.
- Experience with Good Clinical Practices (GCP) and/or Good Laboratory Practices (GLP) data-handling procedures and guidelines.
- Knowledge of drug and disease terminology and the ability to review clinical research protocols, reports, and statistical analysis plans.
