Senior Clinical Trial Manager

IMVT Corporation; United States; Remote; USD 170,000 - 180,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Trial Manager to lead and manage clinical trials in a dynamic environment. This role involves overseeing all aspects of clinical trial operations, from study start-up to close-out, ensuring compliance with regulatory standards and effective collaboration with cross-functional teams. The ideal candidate will possess extensive experience in clinical trial management, exceptional project management skills, and the ability to thrive in a fast-paced setting. This innovative firm offers a competitive salary package, including equity options and a comprehensive benefits plan, making it an exciting opportunity for those passionate about advancing healthcare solutions.

Benefits

Unlimited Paid Time Off

Parental Leave

Medical Insurance

Dental Insurance

Vision Insurance

401k Plan

Qualifications

• 8+ years of experience in clinical trials with at least 3 years in project management.
• Strong knowledge of ICH/GCP guidelines and clinical trial regulations.

Responsibilities

• Lead study start-up, maintenance, and close-out activities for clinical trials.
• Coordinate with CROs and vendors to ensure compliance and timely execution.

Skills

Project Management

Clinical Trial Management

Communication Skills

Risk-based Monitoring

Pharmacovigilance

Multitasking

Education

BA/BS in Clinical or Scientific Discipline

Tools

EDC

IWR

eCOA

Job description

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.
• 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
• 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%)

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.