Quality Assurance Manager
Biofusion · Austin, TX · Yesterday
Quality AssuranceFull-time
About the role
The Clinical Operations Specialist will support the operational aspects of clinical trials. Key responsibilities include managing trial logistics, ensuring compliance with protocols, and assisting with data collection. You will work closely with clinical teams to facilitate smooth trial execution.
Responsibilities
- Support clinical operations in various projects
- Assist in the development of operational strategies
- Monitor project timelines and deliverables
- Collaborate with external vendors
- Lead and manage clinical research projects
- Develop study protocols and budgets
- Ensure compliance with ethical standards
- Mentor junior staff and researchers
- Coordinate daily operations of clinical trials
- Assist in patient recruitment and retention
- Maintain study documentation and records
- Facilitate communication between teams
- Oversee data management processes for clinical trials
- Ensure data integrity and accuracy
- Collaborate with cross-functional teams
- Prepare data reports for stakeholders
- Manage clinical trials from initiation to completion
- Ensure compliance with regulatory requirements
- Coordinate with investigators and site staff
- Monitor patient recruitment and data collection
Requirements
- Bachelor's degree in Health Sciences, Life Sciences, Nursing, or related field
- 2+ years of experience in clinical operations, clinical research, or project management
- Strong organizational and multitasking skills
- Ability to work independently and as part of a team
- Strong communication and problem-solving skills
- Familiarity with clinical trial processes, GCP, and FDA regulations
Qualifications
- PhD in Clinical Research or related field for senior roles
- Master's degree in Data Science or related field for data management roles
- 5+ years of experience in clinical research management for senior roles
- Strong leadership and project management skills
- Excellent analytical and problem-solving abilities
- Proficiency in statistical software
- Knowledge of clinical trial regulations and guidelines
Skills
- Strong organizational and multitasking skills
- Ability to work independently and as part of a team
- Strong communication and problem-solving skills
- Excellent analytical and leadership abilities
- Proficiency in statistical software and data management tools