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Job Description
- Req#: R2795
Employer Industry: Biotechnology
Why consider this job opportunity:
- Salary up to $44.00 per hour for highly experienced candidates
- Eligibility for a discretionary bonus and equity award
- Comprehensive benefits package including medical, dental, and vision plans
- Opportunity for career advancement and professional development within a growing company
- Flexible working environment with options for remote work
- Supportive and collaborative team culture focused on innovation in cancer treatment
What to Expect (Job Responsibilities):
- Maintain the Trial Master File (TMF) during trial activation and closeout phases
- Generate and deliver TMF performance metrics for various functional areas
- Conduct periodic reviews of quality issues and document quality reviews
- Respond to TMF alerts and manage quality issues as a Subject Matter Expert (SME)
- Ensure compliance with regulatory guidelines and support inspection readiness goals
What is Required (Qualifications):
- Bachelor's degree with 3+ years of relevant Trial Master File experience; or High School diploma with 6+ years of relevant clinical research experience
- Experience in study start-up, maintenance, and document quality reviews
- Proven ability to manage projects and handle multiple tasks in a fast-paced environment
- Knowledge of ICH, FDA, and other applicable regulations/guidelines
- Proficiency in MS Office applications and experience with eTMF maintenance preferred
How to Stand Out (Preferred Qualifications):
- Relevant experience in clinical trials, clinical operations, or project management
- Previous use of Veeva Vault for TMF management
- Ability to adapt to changing environments and prioritize tasks effectively
- Strong organizational and time management skills
- Excellent communication and interpersonal skills
#Biotechnology #ClinicalResearch #CareerOpportunity #FlexibleWork #HealthcareInnovation
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