*this is a hybrid position, candidates will be required to frequently travel to the Basel office.
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. 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. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.
If you are an experienced Clinical Trial Associate (CTA) looking to grow your career in the clinical operations industry, and you want a meaningful job in an outstanding company, then keep reading!
As a Senior CTA at Mirum, you will play a crucial part in the study management team. You will be coordinating various administrative aspects of the Sponsor’s project management and oversight activities. You will partner with our Clinical Project Managers and Clinical Research Associates to provide administrative expertise to multiple clinical study management teams. You will help to define and implement meaningful oversight of CROs by supporting with study start-up activities, tracking study progress, overseeing the trial master file quality and completeness, maintaining meeting agendas and minutes, and implementing learnings/sharing knowledge with other study management teams within Mirum. You will work with a high degree of independence and provide administrative support and guidance to help the team achieve high performance and quality project deliverables.
Our team is very diverse and energetic, we work hard, celebrate accomplishments, care about each other, and have fun along the way. On top of that Mirum was recently certified as a Great Place to Work.
To support the Study Management Teams with the following:
- Build a strong relationship with the European Investigators and site staff and ensure our sites get the support they need.
- Study start-up activities
- Site and vendor management
- Writing and distributing meeting agendas and meeting minutes
- Organizing and planning of meetings (e.g. agendas, minutes, rooms, participants).
- Creating and managing trackers and logs for oversight of clinical trials
- Ensuring a high-quality filing structure and archiving of trial documents
- Oversight, maintenance and regular checks of trial master file
- Degree in health care, life sciences or related fields preferred.
- Strong organization skills.
- Minimum 2 years of experience from a CTA position or similar position supporting clinical trial conduct is required.
- Experience working with Trial Master Files
Knowledge, Skills and Abilities:
- Basic knowledge of clinical trial processes and ICH/GCP guidelines.
- Proficient in the use of Microsoft Office.
- Well-organized with excellent time management skills.
- Good written and verbal communication skills.
- Good written and spoken English.
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.
Mirum Pharmaceuticals is also committed to the safety and wellbeing of all who work with us. As we continue to monitor the COVID-19 pandemic, Mirum Pharmaceuticals has made the decision to require all perspective candidates and independent contractors in the United States to be fully vaccinated against the COVID-19 virus. To be considered fully vaccinated is to have both doses of a two-dose vaccine two weeks apart or two weeks since a single-dose vaccine has been administered. This does not apply to candidates/independent contractors who are granted an accommodation/exemption by Mirum Pharmaceuticals based on qualifying religious or medical reasons.
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