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 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
Provide study level requirements for insurance needs to central team
Provide review of regulatory submission and regulatory greenlight packages
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
Support planning activities for offsite study meetings and site visits
Requirements:
BA/BS in a clinical or scientific discipline; at least 4 years of industry experience; working with a pharmaceutical / CRO or healthcare industry
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%)
Compensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $100,000.00 - $115,000.00.
No salary data published by company so we estimated salary based on similar jobs related to Travel and Non Tech jobs that are similar:
$95,000 — $136,250/year
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