Senior Clinical Trial Manager

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as a Senior Clinical Trial Manager. You will be a key player on a dynamic team, advancing rare disease clinical trials. Responsibilities include leading study start-up and maintenance activities, managing CROs and vendors, and ensuring study deliverables are met. You will also liaise with internal and external teams, develop study plans, and lead study close-out activities. The role requires a BA/BS in a clinical or scientific discipline, at least 8 years of clinical trial experience, and 3 years of project management experience. A dynamic, remote-based work environment is offered, with potential for domestic travel.

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
• 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

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

Preferred Qualifications

CRO experience preferred

Benefits

• Remote-based, will have access to Immunovant’s NY / NC offices
• Domestic travel may be required (up to 10%)
• Salary range for posting $170,000 — $180,000 USD
• 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