Associate I, TMF Operations
New
RomaniaFull-TimeEntry
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum 6 months of relevant TMF experience
- Required Skills
- SharePointMicrosoft Excel
Requirements
- Minimum 6 months of relevant TMF experience.
- Knowledge of working within a highly regulated industry, preferably CRO or Pharma.
- University degree preferred.
- Data collection, indexing, and editing skills with adherence to naming conventions.
- Excellent written and verbal communication skills.
- Ability to work with internal teams under general direction.
- Sound judgment and ability to identify when supervisory approval is needed.
- Proficiency in Microsoft Word and Excel.
- Willingness to develop proficiency in electronic document repositories and eTMF systems.
- General understanding of clinical research principles and processes.
Responsibilities
- Fulfil the TMF Approver role according to SOPs and working practices.
- Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
- Utilize Electronic Document Management and eTMF systems to classify and process essential documents.
- Communicate trends and issues directly to the RMC Lead.
- Escalate TMF quality issues to the RMC Lead in a timely manner.
- Provide administrative support by maintaining internal study documents on SharePoint, including quality control checklists and trackers.
View Full Description & ApplyYou'll be redirected to the employer's site
