I

Sr Clinical Trial Associate

Imvt Corporation

Date listed

3 weeks ago

Employment Type

Full time

Remote

Yes

Found on:

Responsive image Remote OK

Keywords: remote gcp

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.  

Salary and compensation

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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