Senior Clinical Trial Associate
Olema Oncology
August 06, 2026
On-site
Cambridge, MA
Clinical Research and Development
Senior Clinical Trial Associate
Responsibilities:
- Provide administrative and operational support across all study activities for in-house and outsourced trials
- Support study start-up, maintenance, and closeout activities
- Manage study-related vendors; serve as point of contact for CROs, contract labs, and other vendors
- Act as key point of contact for investigator sites to coordinate study-related activities
- Oversee sample collection, shipment, and analyses
- Reconcile and track study processes; identify risks and proactively resolve issues with CROs
- Assist with vendor management plans and compile study/quality metrics for CTL and review meetings
- Maintain documentation and correspondence with vendors and sites
- Ensure receipt, completeness, accuracy, and appropriate filing (TMF, SharePoint, and other systems) of clinical/administrative documents
- Support central IRB submissions and review site-specific informed consent forms
- Coordinate electronic distribution and/or shipment of study materials
- Track vendor and site contracts, budgets, invoices, and payments
- Contribute to TMF plan; perform periodic QC reviews and TMF reconciliation
- Perform study/department administrative tasks (agendas, minutes, meeting planning/presentations)
Qualifications:
- Bachelor’s degree required
- Minimum 3 years related industry experience required; Senior CTA requires 2 years as Clinical Trial Associate
- Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines preferred
- Working knowledge of clinical protocols
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook
- Experience leading small group meetings and/or managing vendor relationships
Skills/Attributes:
- Highly motivated; works well in a fast-paced environment
- Excellent teamwork, organization, detail orientation, and written/verbal communication
- Ability to accommodate flexible schedule per trial priorities
Benefits/Compensation:
- Base pay range: $110,000–$115,000 annually; total compensation includes equity, bonus, and benefits
Responsibilities:
- Provide administrative and operational support across all study activities for in-house and outsourced trials
- Support study start-up, maintenance, and closeout activities
- Manage study-related vendors; serve as point of contact for CROs, contract labs, and other vendors
- Act as key point of contact for investigator sites to coordinate study-related activities
- Oversee sample collection, shipment, and analyses
- Reconcile and track study processes; identify risks and proactively resolve issues with CROs
- Assist with vendor management plans and compile study/quality metrics for CTL and review meetings
- Maintain documentation and correspondence with vendors and sites
- Ensure receipt, completeness, accuracy, and appropriate filing (TMF, SharePoint, and other systems) of clinical/administrative documents
- Support central IRB submissions and review site-specific informed consent forms
- Coordinate electronic distribution and/or shipment of study materials
- Track vendor and site contracts, budgets, invoices, and payments
- Contribute to TMF plan; perform periodic QC reviews and TMF reconciliation
- Perform study/department administrative tasks (agendas, minutes, meeting planning/presentations)
Qualifications:
- Bachelor’s degree required
- Minimum 3 years related industry experience required; Senior CTA requires 2 years as Clinical Trial Associate
- Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines preferred
- Working knowledge of clinical protocols
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook
- Experience leading small group meetings and/or managing vendor relationships
Skills/Attributes:
- Highly motivated; works well in a fast-paced environment
- Excellent teamwork, organization, detail orientation, and written/verbal communication
- Ability to accommodate flexible schedule per trial priorities
Benefits/Compensation:
- Base pay range: $110,000–$115,000 annually; total compensation includes equity, bonus, and benefits