TMF Specialist

4 weeks ago


Bengaluru, Karnataka, India Thepharmadaily Full time
Job Description

- Process study documents in line with client and study requirements, adhering to ICON SOPs/WPs and relevant regulations.
- Liaise with study teams and other TMF staff to fulfill responsibilities effectively.
- Complete departmental projects as assigned, ensuring adherence to timelines and regulations.
- Maintain study files per study/client requirements and ICON SOPs/WPs.
- Handle document receipt and processing tasks, including reviewing, scanning, indexing, and archiving.
- Provide necessary information for client and departmental status reports as requested.
- Inform the Manager of training issues, project activities, quality issues, and timelines.
- Participate in audits and document archiving activities as needed.
- Assist in training sessions related to your responsibilities.
- Address project issues with clients as directed by the Manager.
- Undertake special projects or additional duties as requested.

Qualifications:

- 1-15 years of TMF (Trial Master File) experience with strong knowledge of clinical study documents.
- Ability to effectively liaise with study project teams, staff, clients, and management.
- Excellent oral and written communication skills.
- Bachelor s Degree in Life Sciences preferred.

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