Beeline Medicines
Biotechnology
SeniorClinicalTrialManager(Lupus)
“Senior Clinical Trial Manager (Lupus) at Beeline Medicines. Skills: Clinical trial operations, Global study execution, Immunology trials. Lead operational strategy. Plan clinical trials”
What You'll Achieve.
Ensure studies delivered on time; Ensure studies within scope; Ensure compliance with regulatory standards; Achieve enrollment goals
Industry & Context.
Problem-solving; Risk mitigation; Issue resolution
Periodic travel to Beeline Medicines offices, Domestic and international travel up to 20%
What They're Looking For.
Must Have
Bachelor’s degree in life sciences, Minimum 5 years of experience in clinical operations, At least 3 years in a Senior CTM role, Proven track record of managing global clinical trials, Experience with biologics, Knowledge of GCP/ICH guidelines, Availability during Eastern Time (ET) business hours
Nice to Have
Advanced degree preferred, Experience in rare autoimmune indications, Familiarity with adaptive trial designs, Experience in early- to late-stage development programs
What You'll Do.
Lead operational strategy
Execute clinical trials
Oversee clinical trials
Serve as primary operational point of contact
Oversee selection of CROs
Oversee management of vendors
Drive site feasibility
Drive site activation
Drive patient recruitment strategies
Manage ongoing site management
Develop study timelines
Maintain study timelines
Develop risk mitigation strategies
Maintain risk mitigation strategies
Develop operational tracking tools
Maintain operational tracking tools
Collaborate on protocol development
Collaborate on CRF design
Collaborate on ICF review
Collaborate on operational study plans
Ensure studies are conducted in compliance
Identify operational issues
Resolve operational issues
Implement mitigation strategies
Oversee data collection activities
Oversee database lock readiness
Support data review processes
Contribute to regulatory filings
Contribute to inspection readiness
Contribute to audit preparation
Provide leadership to Clinical Operations team
Provide mentorship to Clinical Operations team
Contribute to process improvement initiatives
How You'll Work.
Team & Collaboration
Internal cross-functional teams; External partners; CROs and vendors; Clinical Operations team members
Process & Methodology
Study timelines, Risk mitigation, Operational tracking
Applying for this Senior Clinical Trial Manager (Lupus) role?
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