Clinical Trial Manager

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

Key Responsibilities: 

• Study feasibility and site selection:
• Develop site profile – what are we looking for in a site with input from clinical team
• 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).
• Review outcomes of questionnaire and make recommendations to the clin team for prestudy visits
• Prepare pre-study visit training
• Review outcomes of pre-study visits and make recommendations for site selection.
• Assist with protocol review and development of master ICF in conjunction with medical writer
• Assist with management of CROs and third-party vendors in line with study and program goals; including reporting metrics with issues escalation as needed
• Assist with review of budget accruals.
• Content reviewer for regulatory submissions and responses
• Owner and reviewer for 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 implementations.
• Coordinate and develop materials for SIVs and CRA training and train CRAs in conjunction with study team and CRO.
• Oversee development and maintenance of FAQ
• Oversee inspection readiness of eTMFs in coordination with eTMF lead with escalation as needed.
• Triage clinical sites questions and ensure resolution
• Execution of the sponsor oversight plan (e.g. visit report reviews, trend analysis) and resolution of site related issues.
• Develop content in conjunction with the clinical team for external meetings (study meetings, investigator, etc.)

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)
• Must have at least 3 years of project management experience 
• Required Phase II/III clinical trial management experience
• Required experience managing CROs for full service trials
• Required experiencing managing all aspect of clinical trial 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

• Understanding of FDA, EMEA, ICH and GCP guidelines, 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 a large number of tasks/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; access to Immunovant’s New York and North Carolina offices available
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic and international travel is required (up to 50%)

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