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Senior Clinical Trial Manager

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 Senior Clinical Trial Manager to play a key role on a highly dynamic, cross-functional team. Reporting to the Director, Clinical Operations, you will be responsible for supporting the advancement of rare disease clinical trials as part of Immunovant’s Clinical Operations Team.

 

Key Responsibilities: 

  • Lead Study Start-up activities, including but not limited to the following
    • Feasibility and site selection:    
      • Develop potential site profile
      • Develop initial site list (with input from CRO and clinical team- clin dev, clin ops, field-based team) including country list and estimate enrollment targets by site. 
    • Coordinate development and review feasibility questionnaire (with input from CRO and clinical team). 
    • Align with CTM on criteria to select sites for prestudy visits  
    • Review prepared pre-study visit training  
    • Assist with protocol review and development of master ICF in conjunction with medical writer 
    • Review local ethics submissions and regulatory greenlight packages 
    • Develop internal and external study plans with the CRO and vendors; document plans to ensure compliance with GCPs, vendor, and in-house procedures 
    • Participate in UAT and other system go-live activities. 
    • Coordinate and develop materials for SIVs and CRA. Responsible for training CRAs in conjunction with the study team and CRO. 
  • Lead Study Maintenance Activities, including but not limited to:
    • Manage CROs and third-party vendors in line with study and program needs goals, including reporting metrics with issues escalation as needed 
    • Participate in the review of budget accruals. 
    • Oversee development and maintenance of FAQ  
    • Oversee inspection readiness of eTMFs in coordination with eTMF lead with escalation as needed. 
    • Triage clinical site questions and ensure the resolution   
    • Ensure execution of the sponsor oversight plan (e.g., visit report reviews, trend analysis) and resolution of site-related issues. 
    • Liaise with other internal functional study leads to ensure study deliverables are met
    • Develop content and lead internal study team meetings
    • Lead and participate in routine Vendor calls
  • Interfaces with cross-functional teams (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors, and Investigators/site staff). Works cross-functionally and with external vendors to proactively manage the execution of the clinical trial.
  • Plan and develop content with the clinical team for external meetings (investigator meetings, study coordinator meetings, etc.) 
  • Attend site visits, as requested.
  • Lead Study Close-Out Activities
    • Ensure timely cleaning and delivery of clinical trial data
    • Oversee inspection readiness of eTMFs in coordination with eTMF lead with escalation as needed. 
    • Assist with the completion of the Clinical Study Report

 

Requirements:

  • BA/BS in clinical or scientific discipline, at least 8 years experience with clinical trials; working with a Sponsor company
  • Must have at least 3 years of project management experience
  • Required Phase II / Phase III clinical trial management experience
  • CRO experience preferred
  • Required experience managing all aspects of clinical trials from start-up, maintenance, through closeout
  • Required experience with managing and coordinating multiple workstreams, both internal and external, such as:
    • EDC
    • IWR
    • eCOA
    • Clinical Drug Supply
    • Risk-based monitoring
    • Pharmacovigilance
    • Labs
    • Clinical monitoring
  • Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations, as well as cross-functional clinical processes, including clinical supply, data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal considerations.
  • Deep understanding of clinical trial operations and management of clinical trials at investigator sites
  • Multitasking ability to oversee many 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
  • 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:

  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Remote-based, will have access to Immunovant’s NY / NC offices
  • Domestic travel may be required (up to 10%)

 

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. The annual base salary for this position ranges from $170,000.00 - $180,000.00.

 

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