Senior Clinical Trial Associate

About the role

Olea Oncology is a clinical-stage biopharmaceutical company focused on transforming the standard of care and improving outcomes for patients with breast cancer and beyond. This role is based out of either our office in San Francisco or Cambridge, with approximately 10% travel required.

Responsibilities

• Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct.
• Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors.
• Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities.
• Conducts oversight of sample collection, shipment, and analyses.
• Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead.
• Identifies potential risks and proactively resolves issues with CROs.
• Aids in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s).
• Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information.
• Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents.
• Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms.
• Coordinates electronic distribution and/or shipment of study-related materials, as appropriate.
• Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed.
• Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF).
• Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations.
• Participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes.

Requirements

• Bachelor’s degree is required.
• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred.
• Working knowledge of clinical protocols.
• Minimum of 3 years of related industry experience is required.
• Senior CTA requires 2 years' experience working as a Clinical Trial Associate.
• Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook).
• Experience with leading small group meetings and/or managing vendor relationships.
• 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, as needed.

Qualifications

• Knowledgeable about clinical protocols and regulatory requirements.
• Strong organizational and administrative skills.
• Effective communication and problem-solving abilities.
• Experience with clinical trial operations and procedures.
• Ability to manage multiple projects simultaneously.

Skills

• Strong organizational and administrative skills.
• Effective communication and problem-solving abilities.
• Experience with clinical trial operations and procedures.
• Ability to manage multiple projects simultaneously.

Benefits

The base pay range for this position is expected to be $110,000 - $120,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.