A company is looking for a Sr. TMF Manager - Clinical Operations.
Key Responsibilities
Maintain Trial Master Files (TMFs) to ensure they are current and inspection-ready
Lead relationships with Contract Research Organizations (CROs) and manage clinical document quality / control / review
Oversee internal e / TMF applications and perform setup activities
Required Qualifications
Understanding of clinical trial conduct and TMF structure (TMF Reference Model)
Experience with eTMF systems or software
Knowledge of best documentation practices
Ability to develop Standard Operating Procedures (SOPs) and user training manuals
Experience in performing User Acceptance Testing (UAT) and validations
Senior Manager • Independence, Missouri, United States