Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.
is seeking a Clinical Trial Associate 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
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic and international travel is required (10%)