Senior 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 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.
- Feasibility and site selection:
- 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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