Sr Clinical Trial Associate Remote
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.
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