Senior Clinical Trial Manager

Summary

Join Immunovant, 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. Reporting to the Director, Clinical Operations, you will lead study start-up and maintenance activities, manage CROs and vendors, and ensure compliance with GCPs. This role requires extensive experience in clinical trial management, strong communication skills, and the ability to manage multiple workstreams. The position is remote-based with potential domestic travel and offers a competitive salary, equity, and a comprehensive benefits package including unlimited paid time off and parental leave.

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

• Full range of medical, dental, vision, 401k, and other benefits
• Unlimited paid time off
• Parental leave
• Equity and other forms of compensation may be provided as part of a total compensation package
• Remote work