Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Immunovant is seeking a (Senior) Clinical Trial Associate to play a key role on a highly dynamic cross-functional team. You will be responsible for administrative support in the advancement of rare disease clinical trials as part of Immunovantâs Clinical Operations team from study start-up to study closure.
- Develop clinical team meeting agendas, minutes, and track follow-up actions
- Ensure inspection readiness of eTMF in conjunction with eTMF lead.
- Maintain a vendor and site contact list
- Triage documents including ICF, CTAs, other documents as required including legal and privacy reviews
- Provide study level requirements for insurance needs to central team
- Provide review of regulatory submission and regulatory greenlight packages
- Coordinate and develop FAQ for clinical sites
- Support CTM is data review activities.
- Ensures access to systems for clinical team members
- Administrative support for the clinical team
- General support for inspectional readiness activities
In addition for Sr. CTA
- Provide support for vendor oversight activities
- Perform content reviews and provide content for informed consents and other study related documents
- Provide support for trial-related budget reviews
- 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 a large number of 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
â¢ Remote-based; Immunovantâs headquarters is in NYC
â¢ Dynamic, interactive, fast-paced, and entrepreneurial environment
â¢ Domestic or international travel is required (10%)