Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
This role is to assist the Study Lead/s in the clinical execution of ongoing as well as upcoming clinical trials. Responsible for providing overall support to clinical study leads in matters related to investigational site management, site relationship building, site compliance, and other study-related activities, including study start-up, interim study monitoring as well as trial closeout activities. Responsible for providing overall support to clinical study leads in vendor oversight (e.g., co-monitoring with CRO CRAs, attending sponsor-CRO calls, tracking compliance).
- Act as a bridge between Mirum and the Investigators/study sites and contribute to building a strong sponsor-site relationship.
- Provide input on patient recruitment strategies and develop recruitment tools.
- Support implementation and ongoing execution of patient recruitment strategies at assigned study sites.
- Act as a first escalation point with Mirum for study sites.
- Assist the Study Leads with Project Management tasks to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs/Study Plans, FDA regulations, and ICH/GCP guidelines.
- Develop and/or contribute to the preparation of study-related documents (protocols, recruitment tools, case report forms/eCRFs, informed consent forms, study plans and manuals, site tools).
- Participate in evaluation, selection, set-up, and management of vendors (CROs, ediaries, labs, central readers etc.) and clinical sites.
- Provide monitoring oversight through review of monitoring schedules, metrics and reports.
- Perform retraining of site staff and/or CRAs as applicable.
- Assist with review of study-specific data in preparation for database lock.
- Responsible for oversight of Trial Master Files (eTMF), including ensuring files maintained by the CRO are inspection-ready.
- Track and prepare study-specific information utilizing databases, spreadsheets, and other tools.
- Participate in cross-functional study team meetings; liaise with other functional areas to coordinate clinical study activities.
- Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework or certifications in clinical trial planning and operations desired.
- At least 5+ years of relevant experience with at least 3 years in a CRA functional role in the pharmaceutical industry.
- Experience working in a fully outsourced model.
- Experience monitoring in Phase 2-3 trials.
- Experience in small, fast-paced biotech is a plus.
Knowledge, Skills and Abilities:
- Must have a demonstrated working knowledge of GCP, ICH guidelines, and regulations.
- Customer-focused, problem solver.
- Strong oral and written communication skills.
- Detail and quality-oriented.
- Strong social skills to build relationships with Investigators and site staff, as well as CROs.
- Able to work independently and within a team.
- Willing to travel up to 30% of the time (post-COVID).
To apply, please send your resume to firstname.lastname@example.org.