Trial Master File (TMF) Quality Control Specialist

Job description

Job Description

Job Purpose

The TMF Quality Control Specialist will assist Clinical teams in a wide variety of Trial Master File duties including quality reviews and completeness checks of global study TMFs in accordance with Novartis SOPs and ICH/GCP guidelines. The TMF Quality Control Specialist will establish and maintain TMF guidance documents and training materials for TCO Clinical Operations. Serve as a TMF subject matter expert (SME) resource on all matters pertaining to TMF maintenance and QC activities across the TCO organization.

Accountabilities (Operational and Subject Matter Expert)
1.Perform QC/completeness checks on all global TCO study TMFs in accordance with Novartis SOPs, working practices and ICH/GCP Guidelines
2.Follow-up with the CTT to resolve quality issues identified in TMFs; Follow-up with the Clinical Quality Manager (CQM) for reporting SOP/WP process deviations
3.Function as Subject Matter Expert (SME) for TCO Clinical Operations/Clinical Trial Teams for TMF related questions and TMF Quality Control
4.Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations.
5.Maintain documentation of appropriate oversight and tracking of all TMF QC activities.
6.Prioritize trial TMF QC activities in accordance with TCO portfolio and Clinical Operations Proof of Concept (PoC) and Clinical Study Report (CSR) dates
7.In collaboration with the Training and Communications line function - develop, optimize and maintain TMF guidance documents, tools and training materials
8.Track TMF key quality indicators (KQIs)s, and overall compliance to TMF processes and regulations.
9.Provide training to the CTTs on TMF processes and QC measures
10.Participate in CTT meetings as needed, support the training of CTTs on TMF and implementation of best practices within CTTs
11.Serve as Subject Matter Expert on CREDI and Subway documentum systems
12.Participate and/or lead meetings related to TMF processes and trainings (e.g. TMF QC Compliance Review Meetings).
13.Participate in the on-boarding and training of new ClinOps staff.
14.Serve as TCO representative on TMF process improvement initiatives, committees, work streams and governances.

Posting Title

Trial Master File (TMF) Quality Control Specialist

Desired profile

Minimum requirements

Education :
B.A. or B.S. preferably in life sciences or equivalent experience

Experience:
1.A minimum 3-5 years of relevant experience in the Pharmaceutical Industry with broad experience in Trial Master File quality management at Global, Country or Site levels
2.Ability to work effectively on either self-managed projects or as a team member
3.Ability to adjust to multiple demands, shifting priorities, and unexpected events in a fast paced environment while maintaining a positive work attitude
4.Self-motivated with a high degree of ownership and accountability for results
5.Developed or have participated in the development of SOPs, guidance documents, work practices and tracking tools
6.Provided training and or mentorship to colleagues on a 1:1 basis or meeting setting
Job Type

Full Time
Country

USA
Work Location

East Hanover, NJ
Functional Area

Quality
Division

NIBR
Business Unit

Oncology NIBR
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.