Senior Clinical Trial Manager
New
B
Beeline MedicinesBiotechnology
United States, Eastern Time (ET)Full-TimeSenior
Salary178,000 - 194,500 USD per year
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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 of managing global, multi-center clinical trials in immunology or autoimmune disease indications.
- Experience with biologics, monoclonal antibodies, or advanced therapies.
- Strong knowledge of GCP/ICH guidelines and clinical trial regulations.
- Proficiency with electronic systems such as CTMS, EDC, eTMF, and risk-based monitoring tools.
- Ability to work independently with minimal supervision.
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.
- Drive site feasibility, selection, activation, and patient recruitment.
- Develop and maintain study timelines, risk mitigation strategies, and tracking tools.
- Ensure compliance with GCP/ICH guidelines and internal SOPs.
- Oversee data collection activities and support data review processes.
- Contribute to regulatory filings, inspection readiness, and audit preparation.
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