Senior Clinical Trial Associate
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Senior Clinical Trial Associate (Sr. CTA) supports the execution and operational management of clinical trials by ensuring efficient coordination of study activities, maintenance of study documentation, and tracking of key deliverables. This role works closely with Clinical Project Managers (CPMs), CROs, and cross-functional teams to support timely, high-quality study execution in compliance with regulatory requirements.
JOB FUNCTIONS/RESPONSIBILITIES
Clinical Trial Execution
- Support day-to-day operational activities across assigned clinical trials.
- Maintain and track study timelines, deliverables, and action items.
- Assist with site start-up, activation, and ongoing site management activities.
- Support patient recruitment and retention efforts in collaboration with the study team.
Study Documentation & TMF
- Ensure completeness, accuracy, and timeliness of Trial Master File (TMF) documentation.
- Support TMF reconciliation activities and ensure inspection readiness.
- Assist with preparation, review, and tracking of essential study documents
Study Tracking & Reporting
- Create and maintain trackers, dashboards, and system reports to support study oversight.
- Support data collection and reporting for internal and external stakeholders.
Cross-Functional Collaboration
- Partner with Clinical Operations, Clinical Development, Data Management, Regulatory, Safety, and CROs to support study execution.
- Communicate effectively with internal teams and external vendors to ensure alignment and timely delivery.
Operational Excellence
- Demonstrate strong organizational skills and attention to detail across multiple studies and priorities.
- Identify operational issues and support implementation of timely solutions.
- Ensure adherence to SOPs, GCP, ICH guidelines, and regulatory requirements.
Mentorship & Team Support
- Support onboarding and mentoring new CTAs.
- Contribute to a collaborative and high-performing team environment.
QUALIFICATIONS
Education/Experience:
- Bachelor’s degree in life sciences, healthcare, or related field (or equivalent experience)
- Experience in clinical research supporting clinical trials
- Experience working within biotech, pharma, or CRO environments
- Working knowledge of GCP and clinical trial processes.
Knowledge, Skills and Abilities:
- Strong organizational and time management skills
- Experience working with Trial Master File (TMF) systems and processes
- Ability to manage multiple priorities in a fast-paced environment
- Strong written and verbal communication skills
- Detail-oriented with a focus on quality and compliance
- Problem-solving mindset with proactive follow-up
- Ability to work independently with minimal oversight
- Strong collaboration and teamwork skills
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.