An organisation is searching for a Senior Clinical Trial Manager, please see some of their job details below.
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 sites questions and ensure 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 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 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
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%)
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#OTHER
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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