Trial Master File Study Owner Jobs (NOW HIRING)

Latigo is seeking a highly organized and detailed oriented Clinical Trial Associate to provide operational and administrative support for Latigo-sponsored clinical trials. This position will support the Clinical Operations team across study start-up, maintenance, and close-out activities, including study document tracking, Trial Master File support, meeting coordination, vendor and site communication, and study systems support. The successful candidate will work closely with the clinical trial leads and cross-functional team members, vendors, and trial sites to help ensure clinical trials are conducted in accordance with study protocols, applicable SOPs and study plans, ICH-GCP, and regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Assist with study start-up activities, including eTMF index/structure review and other eTMF set-up activities, collection and tracking of essential documents, site contact information, regulatory documents, training documentation, and review of study-specific materials.
• Oversee the maintenance of the electronic Trial Master File (eTMF) for all assigned studies, in accordance with applicable study plans, and SOPs. Ensure timely and accurate filing of documents by the CRO. Perform interim quality checks of the eTMF during study conduct, and prior to final eTMF transfer.
• Organize and maintain the internal study Sharepoint site for assigned studies.
• Maintain study trackers, contact lists, meeting action item logs, training trackers, vendor trackers, and other study management tools to support accurate and timely study oversight.
• Schedule study meetings, prepare agendas, draft meeting minutes, distribute follow-up items, and track action items through resolution, as assigned.
• Support clinical trial systems and portals, including access requests, user tracking, document uploads, and follow-up on system-related issues as appropriate.
• Assist with review and reconciliation of study documents, site correspondence, monitoring documentation, safety-related documentation, and vendor deliverables, as assigned.
• Coordinate logistics for investigator meetings, study team meetings, site training, vendor meetings, and other clinical trial activities, as required.
• Assist with tracking clinical trial milestones, deliverables, risks, issues, and decisions. Escalate delays or issues to the Clinical Trial Manager or study lead.
• Support backroom operations during regulatory inspections
• Support invoice, budget, contract, and work order tracking.
• Maintain awareness of applicable clinical research regulations, ICH-GCP guidelines, study protocols, SOPs, and project-specific plans.
• Perform other clinical operations duties as assigned.

QUALIFICATIONS

• Bachelor's degree or equivalent, preferably in a scientific discipline or health-related field
• Minimum of 2 years of relevant industry experience
• Working knowledge of clinical trial conduct, study start-up, maintenance, and close-out activities.
• Familiarity with ICH-GCP, CFR, and other applicable regulatory requirements for clinical trial conduct.
• Experience supporting Trial Master File activities preferred.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced, cross-functional environment.
• Excellent written and verbal communication skills
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.
• Ability to collaborate effectively with internal study teams and vendors
• Demonstrated ability to follow established processes, identify issues, escalate appropriately, and support timely resolution of action items.

WORK ENVIRONMENT AND TRAVEL

• This position may be based in Thousand Oaks, CA or San Francisco, CA, with hybrid or office-based expectations to be determined based on business needs.
• Occasional travel may be required for study team meetings, vendor meetings, site visits, or other clinical trial activities.
• The role requires effective collaboration across time zones and with internal and external stakeholders.