Senior Clinical Trial Manager

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%)