Beeline Medicines
Biotechnology
SeniorClinicalTrialManager(AtopicDermatitis)
“Senior Clinical Trial Manager (Atopic Dermatitis) at Beeline Medicines. Skills: Clinical trial management, Immunology, Autoimmune diseases. Lead operational strategy. Plan clinical trials”
What You'll Achieve.
Ensure studies delivered on time; Ensure studies within scope; Ensure studies compliance; Achieve enrollment goals
Industry & Context.
Problem-solving; Risk mitigation; Issue resolution
Travel up to 20%, Domestic travel, International travel, Overnight stays, Availability during Eastern Time
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, Experience in early- to late-stage development programs
Nice to Have
Advanced degree preferred, Experience in rare autoimmune indications, Familiarity with adaptive trial designs, Experience with complex biomarker-driven studies
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 vendor selection
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 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 team members
Provide mentorship to team members
Contribute to process improvement initiatives
How You'll Work.
Team & Collaboration
Internal cross-functional teams; External partners; CROs; Vendors; Sites; Clinical Operations team members
Process & Methodology
Clinical trial management, Risk mitigation, Timeline management
Applying for this Senior Clinical Trial Manager (Atopic Dermatitis) role?
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