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Senior Clinical Trial Associate

Remote

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%)

 

 

Salary range for posting

$80,000 - $110,000 USD

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity 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.

 

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