Senior Clinical Trial Manager
E
Entrada TherapeuticsBiopharmaceutical
This is a US based remote positionFull-TimeSenior
Salary160,000 - 185,000 USD per year
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Job Details
- Experience
- 7+ years
Requirements
- BA/BS degree required.
- 7+ years of combined experience supporting and independently managing clinical trial activities.
- Strong knowledge of ICH/GCP and regulatory requirements.
- Experience with global trials and EU-CTR preferred.
- Extensive experience in the drug development process, including trial design, planning, and management.
- Proven track record in CRO and vendor oversight.
- Excellent verbal and written communication skills.
- Demonstrated ability to work effectively across cross-functional teams.
- Ability to travel approximately 20% of the time.
Responsibilities
- Own all operational aspects of designated clinical trials, including CRO and vendor management.
- Manage study activities such as vendor selection, site selection, informed consent development, and eCRF design.
- Proactively identify and support resolution of trial conduct issues.
- Lead or support cross-functional trial teams through trial execution and closeout.
- Provide regular trial progress updates to internal stakeholders regarding enrollment, eligibility, and reporting.
- Oversee clinical monitoring from site qualification to closure, ensuring data integrity and documentation accuracy.
- Support clinical data review, cleaning, and reconciliation for database lock.
- Develop and implement study-specific training for internal, CRO, and site staff.
- Maintain study budgets and ensure accurate forecasting in collaboration with business operations.
- Conduct site visits as needed to support monitoring activities.
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