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About the Role

Provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff.

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
• Assists 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
• Actively 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

• 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

Skills

• Clinical trial administration
• Vendor management
• Site communication
• Sample tracking
• Issue escalation
• Risk identification
• Study plan development
• Document filing
• IRB submission support
• Material coordination
• Contract and budget tracking
• Trial Master File (TMF) management
• Meeting agenda and minute preparation
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Outlook

Location

• San Francisco
• Cambridge

Work Type

• Hybrid

Experience Level

• Senior

Education Level

• Bachelor's degree

Salary/Compensations

• $100,000 - $115,000

Benefits

• Equity
• Bonus
• Competitive compensation and benefits package
• Open, flexible, and friendly work environment

About the Company

• Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond.
• Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials.
• Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant.
• Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer.
• We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution.
• Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day.

Equal Opportunity

• We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience.
• Olema is building a culture where the value of difference is celebrated.