Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.
is seeking a Clinical Trial Assistant to play a key role on a highly dynamic cross-functional team. Reporting to a Sr. Director of Clinical Operations, you will be responsible for administrative support in the advancement of rare disease clinical trials as part of Clinical Operations team from study start-up to study closure.
- In collaboration with Sr. Director Clinical Operations, support the study operational strategies.
- Assist with budget monitoring including invoicing and confirmation of site payments.
- Develop meeting agendas, minutes and track follow-up actions
- Ensure eTMF oversight including routine quality checks to maintain a complete and inspection-ready state.
- Maintain a vendor and site contact list
- Work with the clinical operations team to maintain clinical trial scorecards for routine review
- Assist clinical sites with questions and resolving queries.
- With oversight from the Sr. Director Clinical Operations, provide support to the multifunctional team on special initiatives as needed.
- Create and improve upon business processes ensure successful growth
- BA/BS in a clinical or scientific discipline; at least 3 years of experience with clinical trials; working with a sponsor company (biotech/pharmaceutical company)
- Additional experience in other related fields or positions, some phase 2/3 and global clinical trial experience is a plus.
- Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, and drug safety.
- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent.
- Understanding of clinical trial operations and management of clinical trials at investigator sites
- Multitasking ability to oversee projects and reach milestones on time
- Exceptional academic and professional accomplishments, indicating critical thinking ability
- Strong written and oral communication skills with incredible attention to detail
- Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades
- Ability to think outside of the box and challenge the status quo
- Natural entrepreneurial spirit with unrelenting dedication to delivering results
- Desire to work in a fast-paced, innovative environment
- Natural collaborator who enjoys working on a cross-functional team
- The position is located at New York Office
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic and international travel is required (10%)