Senior Clinical Trial Associate

About the role

The Senior Clinical Trial Associate plays a critical role in supporting the Clinical Trial Lead and Study Execution Team. They ensure accurate and essential documentation of study conduct, manage vendors, and coordinate with investigator sites. Key responsibilities include:

• Supporting study start-up, maintenance, and closeout activities
• Managing study-related vendors and serving as a point of contact for contracted CROs
• Facilitating communication and coordination with investigator sites
• Conducting oversight of sample collection, shipment, and analyses
• Identifying potential risks and proactively resolving issues with CROs
• Assisting in the development of vendor management and other study plans
• Ensuring receipt, completeness, accuracy, and appropriate filing of clinical and administrative documents
• Coordinating electronic distribution and/or shipment of study-related materials
• Collaborating with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and payments
• Contributing to the development of the TMF plan and conducting periodic quality control reviews and records reconciliation
• Performing study and departmental administrative and clerical duties

Responsibilities

Primary responsibilities include:

• Supporting the Clinical Trial Lead (CTL) and Study Execution Team (SET)
• Managing study-related vendors and serving as a point of contact for contracted CROs, study staff, contract labs, and other study vendors
• Acting as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities
• Conducting oversight of sample collection, shipment, and analyses
• Identifying potential risks and proactively resolving issues with CROs
• Assisting in the development of vendor management and other study plans
• Ensuring receipt, completeness, accuracy, and appropriate filing of clinical and administrative documents
• Coordinating electronic distribution and/or shipment of study-related materials
• Collaborating with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and payments
• Contributing to the development of the TMF plan and conducting periodic quality control reviews and records reconciliation
• Performing study and departmental administrative and clerical duties

Requirements

Minimum qualifications include:

• Bachelor’s degree
• Minimum of 3 years of related industry experience
• Senior CTA requires 2 years' experience working as a Clinical Trial Associate
• Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook)

Qualifications

Preferred qualifications include:

• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines
• Experience with leading small group meetings and/or managing vendor relationships

Skills

Essential skills include:

• A love of challenging, important work
• Highly motivated and enjoys working in a fast-paced, dynamic environment
• Excellent teamwork and collaboration skills
• Good organizational skills, ability to manage multiple tasks, and meticulous attention to detail
• Excellent written and verbal communication skills
• Ability to accommodate a flexible work schedule according to clinical trial(s) priorities

Benefits

Olema Oncology offers a competitive compensation and benefits package, including equity, bonus, and benefits. For more information about our benefits, please refer to the Summary of Benefits.