Clinical Trial Associate

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%)

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