Senior Clinical Trial Manager
New
B
Beeline MedicinesBiotechnology
United States, Eastern Time (ET) business hoursFull-TimeSenior
Salary$150,000 — $194,500 USD
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Job Details
- Experience
- Minimum 5 years of experience in clinical operations in the biopharmaceutical industry, with at least 3 years in a Senior CTM or equivalent leadership role.
- Required Skills
- GCP
Requirements
- Bachelor’s degree in life sciences or related field (advanced degree preferred).
- Minimum 5 years of experience in clinical operations in the biopharmaceutical industry.
- At least 3 years in a Senior CTM or equivalent leadership role.
- Proven track record managing global, multi-center clinical trials in immunology or autoimmune indications.
- Experience with biologics, monoclonal antibodies, or advanced therapies.
- Strong knowledge of GCP/ICH guidelines and clinical trial regulations.
- Experience in early- to late-stage development programs and pivotal trials.
- Proficiency with CTMS, EDC, eTMF, and risk-based monitoring tools.
- Availability during Eastern Time (ET) business hours.
- Ability to travel domestically and internationally up to 20% or more.
Responsibilities
- Lead the operational strategy, planning, and execution of global Phase 1–4 clinical trials in immunology indications.
- Serve as the primary operational point of contact for internal stakeholders and external partners.
- Oversee the selection and management of CROs and other vendors, including budget and performance oversight.
- Drive site feasibility, selection, activation, and recruitment strategies.
- Collaborate on protocol development, CRF design, and ICF review.
- Ensure studies are conducted in compliance with GCP/ICH guidelines and internal SOPs.
- Oversee data collection activities, database lock readiness, and support inspection/audit preparation.
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