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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Trial Master File (TMF) documentation, ensuring compliance with regulatory standards, and collaborating with cross-functional teams in the clinical research environment. Strong organizational and communication skills are essential for maintaining the accuracy and completeness of essential documents throughout clinical trials.
Highest-signal resume keywords
Trial Master File ManagementClinical Research ExperienceRegulatory ComplianceDocument ManagementCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
TMF DocumentationQuality ChecksAuditsRegulatory SubmissionsDocument Review
Soft Skills
Attention to DetailOrganizational SkillsCommunication SkillsPartnership Skills
Industry Keywords
Pharmaceutical IndustryBiotechnologyCRO IndustryLife Sciences
About the role
Key responsibilities & impact- Manage Trial Master File (TMF) documentation in accordance with client requirements and ICON procedures
- Ensure the completeness, accuracy, and timeliness of TMF documentation throughout the lifecycle of clinical trials
- Partner with cross-functional teams to collect, review, and maintain essential documents for regulatory submissions
- Conduct quality checks and audits of TMF documents to ensure compliance with regulatory standards and sponsor requirements
- Provide efforts and guidance to internal and external stakeholders on TMF-related matters
Requirements
What you’ll need- A minimum of 3 years of experience in clinical research or document management within the pharmaceutical, biotechnology, or CRO industry
- Bachelor's degree in life sciences, documentation management, or a related discipline
- Strong attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously
- Excellent communication skills, with the ability to partnership effectively with cross-functional teams
- Willingness to travel as required (approximately 5%)
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways