TMF Domain Expert- Sponsor dedicated

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

TMF Domain Expert - Novartis dedicated

Senior Domain Expert for Trial Master File (TMF) documents to support Source-to-Target Migrations of Clinical Documents. This resource will lead Migration Data Preparation activities and assist to determine all properties and attributes for all types of TMF documents. 

Major Accountabilities:  

• Collaborate with external vendor and NVS internal functions to:
• Build, expand and automate the migration approach for TMF documents from Source to Target System
• Build, expand and automate the Attribute Extraction Approach to determine mandatory document properties
• Coordinate & oversee processes supporting extraction and migration activities by:
• Driving Quality Control activities to ensure that the migration / migration automation process is producing high quality outputs
• Coordinating and participating in Test Activities
• Ensuring appropriate completeness checks for the Trial Master File (TMF) records of migrated clinical studies
• Collaborate closely with CDGM organisation and business process owners to ensure alignment of migration activities with parallel system and/or process updates.
• Engage with stakeholders in the Novartis organization to align on migration requirements, migration approach and missing or erroneous information in source system
• Support Novartis Digital ambitions and gain insights on Artificial Intelligence projects

The above responsibilities are to a large extent based on interdisciplinary topics and require the employee to liaise, cooperate with and coordinate numerous related functions such as users from different business areas, CDGM functions, IT, QA, etc.

Key Performance Indicators (Indicate how performance for this role will be measured)

• Consistency, Compliance and Integrity enabled for TMF Migration Processes
• Adherence to Novartis Standards and Stakeholders Expectations on TMF Migrations

Experience/Professional requirement:

• Minimum Bachelor’s degree in life science/healthcare or equivalent
• Fluent English (oral and written), German of advantage  
• Minimum 10+ years experience in LifeScience Industry
• Extensive experience with usage of clinical document management systems
• Working knowledge of clinical essential documents, including Trial Master File (TMF)
• Relevant clinical research experience in industry or in clinical practice such as  trial/study coordinator
• Experience with coordinating deliverables from 3rd party vendors
• Knowledge of ICH GCP, 21 CFR part11
• Experience with Documentum based D2LS system is a plus.
• Experience with Document Migration Projects is a plus
• Experience working as Business Analyst is a plus

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.