Clinical Trial Manager, Clinical Operations
New
S
Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeManager
Salary135,000 - 155,000 USD per year
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Job Details
- Experience
- 5 years of clinical research experience
- Required Skills
- Cross-functional Team Leadership
Requirements
- B.A./B.S. in life sciences or equivalent.
- Minimum 5 years of clinical research experience in pharma or biotech.
- At least 2+ years managing early phase clinical trials.
- Inflammation and/or Immunology experience preferred.
- Strong working knowledge of clinical operations.
- Experience with clinical study conduct from start-up through close-out.
- Informed consent development and EU CTR experience.
- Ability to lead cross-functional study teams in a matrix organization.
- Working knowledge of FDA/ICH guidelines and Good Clinical Practices.
Responsibilities
- Manage clinical trials from vendor selection through Clinical Study Report completion.
- Ensure activities meet quality standards including ICH/GCP requirements.
- Create and implement study-specific clinical monitoring tools.
- Lead identification, evaluation, selection, and oversight of clinical trial sites.
- Author and implement operational plans for study enrollment and site monitoring.
- Review/approve vendor and site invoices and manage study budget.
- Implement and oversee the Trial Master File.
- Lead internal and external meetings including Investigator Meetings.
- Perform ongoing study data reviews and data cleaning.
- Manage trial-level quality risk management and study supply oversight.
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