Home > Find Jobs

Job Search

A tropical beach
IMVT Corporation company logo

IMVT Corporation

New York City, New York, United States

Posted on: 22 November 2023

Experience

n/a

Work

n/a

Employee Type

n/a

Salary Range

n/a

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%)

 



Please mention the word **ASTOUNDING** and tag RMTg4LjE2Ni4xMDAuMTkx when applying to show you read the job post completely (#RMTg4LjE2Ni4xMDAuMTkx). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.

Tags

support
travel
management
content
operations
legal
non tech
Apply to job