Olema Oncology
Senior Clinical Trial Associate
San Francisco, California · Senior
Sponsorship not specified$100k-$115kDetected 14 days ago
GCPExcelVendor ManagementFDA RegulatoryCommunicationCollaborationPublic SpeakingAdaptabilityOrganizational SkillsMicrosoft OfficeSharePointGxP
About the role
- 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.
- OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients.
- 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.
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
- Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead
- 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.
- Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed
- Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations
- Good organizational skills, ability to manage multiple tasks and meticulous attention to detail
Requirements
- Bachelor's degree is required
- Minimum of 3 years of related industry experience is required
- Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook)
- Experience with leading small group meetings and/or managing vendor relationships
Compensation
- The base pay range for this position is expected to be $100,000 - $115,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.
Benefits
- 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
- Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed
Company info
- We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers.
- To protect yourself, please note that Olema's official email addresses end in @olema.com.
- Our official corporate website is <a cla
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