Overview

Organizational Overview:

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. 

The Role:

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 Immunovant’s Clinical Operations team from study start-up to study closure.

Key Responsibilities:

  • 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

Requirements:

  • 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

Work Environment:
• Remote-based; Immunovant’s headquarters is in NYC
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (10%)