Employer Industry: Biotechnology

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Collaborative and innovative work environment
- Chance to contribute to significant advancements in clinical research
- Work with a dedicated team focused on improving patient outcomes
- Competitive salary and benefits package

What to Expect (Job Responsibilities):
- Manage and optimize electronic and physical Trial Master Files (eTMFs/pTMFs/TMFs) for clinical trials
- Ensure compliance with regulatory requirements and internal policies
- Collaborate with cross-functional teams to facilitate trial documentation processes
- Conduct regular audits and inspections of TMF documents to maintain quality standards
- Provide training and support to junior staff on TMF best practices

What is Required (Qualifications):
- Minimum of 5 years of experience in clinical trial management or related field
- In-depth knowledge of TMF processes and regulatory guidelines
- Strong organizational skills and attention to detail
- Excellent written and verbal communication skills
- Proficiency in electronic TMF systems and document management software

How to Stand Out (Preferred Qualifications):
- Experience working in a biotechnology or pharmaceutical company
- Certification in Clinical Research or Trial Master File management
- Familiarity with Good Clinical Practice (GCP) and other relevant regulations
- Demonstrated ability to lead projects and mentor junior team members

#Biotechnology #ClinicalResearch #CareerOpportunity #TMFManagement #RegulatoryCompliance

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