Local Trial Manager - Thousand Oaks, CA

Military Spouse Corporate Career Network • Thousand Oaks, CA

1d • $138,320 - $163,992 • Onsite

About The Position

The Local Trial Manager plans, manages, and oversees clinical study implementation in accordance with the global program strategy, leading engagement of the cross-functional Local Study Team. The role partners with global and local country teams to establish country strategy and drive study progress and local study delivery. It communicates country status, timelines, and results to key partners and updates relevant systems for transparency. The position provides country-level input to the Country Operational Plan and partners with the Development Feasibility Manager during feasibility and Global Clinical Managers to support local study delivery. It also assigns and delivers study support staff and continually reviews country-level risk mitigation to keep studies on plan. The role may telecommute; the posting otherwise describes the position as on-site in Thousand Oaks, California.

The role also processes clinical data; monitors productivity and quality for compliance with standard operating procedures; contributes to controlled documentation such as protocols, clinical study reports, and regulatory submissions; maintains awareness of database technology and best practices; and provides support to areas including marketing, clinical monitoring, and medical affairs. It supports audits and inspections and contributes to CAPAs, including leading issue resolution when appropriate.

Requirements

• Master’s degree or foreign equivalent in Drug Regulatory Affairs, Biology, Chemistry, or a related field.
• Three years of experience in the job offered or in a clinical trial-related occupation.
• Three years of experience applying ICH E6 (R2) Good Clinical Practice and related ICH guidelines in managing global clinical trials.
• Three years of experience interpreting and implementing FDA regulations (21 CFR Parts 11, 50, 54, 56, and 312) and other applicable regulatory requirements in clinical trial execution.
• Three years of experience managing clinical trial activities from study start-up through close-out in accordance with regulatory and protocol requirements.
• Three years of experience developing and monitoring Country Operational Plans, study timelines, milestone tracking, and enrollment forecasting.
• Three years of experience managing and overseeing external vendors, including CROs, central laboratories, imaging vendors, and IRT providers.
• Three years of experience using EDC systems, including Medidata Rave, for clinical data oversight and monitoring.
• Three years of experience using eTMF systems, including Veeva Vault TMF, to ensure documentation completeness and inspection readiness.
• Three years of experience using CTMS to track study progress, budgets, and performance metrics.
• Three years of experience overseeing IRT/IWRS/IVRS systems for enrollment tracking and investigational product management.
• Three years of experience monitoring and analyzing time, cost, and quality performance metrics, including KPIs.
• Three years of experience identifying, assessing, and mitigating regulatory and operational risks using RBQM principles.
• Three years of experience supporting and coordinating regulatory submissions, including ethics committee and IRB applications and health authority communications, and supporting clinical-to-commercial transition activities.
• Three years of experience leading or supporting regulatory inspections, internal audits, and CAPA development and implementation.
• Three years of experience applying ALCOA+ data integrity principles in oversight of clinical trial documentation and records.
• Three years of experience coordinating cross-functional teams to align with global program strategy and regulatory compliance requirements.

Responsibilities

• Process clinical data, including receiving, entering, verifying, or filing information.
• Monitor work productivity and quality to ensure compliance with standard operating procedures.
• Contribute to compiling, organizing, and producing protocols, clinical study reports, regulatory submissions, and other controlled documentation.
• Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices.
• Provide support and information to functional areas such as marketing, clinical monitoring, and medical affairs.
• Partner with global and local country teams on country strategy and drive study progress and local/country-level study delivery.
• Plan, manage, and oversee clinical study implementation in accordance with global program strategy through leadership and engagement of the cross-functional Local Study Team.
• Communicate country status, timelines, and results to key partners and update relevant systems for transparency.
• Provide country-level input to the Country Operational Plan and partner with the Development Feasibility Manager during feasibility and Global Clinical Managers to ensure local study delivery.
• Support internal audits and inspections and contribute to CAPAs, including leading issue resolution when appropriate.
• Assign and deliver study support staff and continually review country-level risk mitigation to ensure study delivery to plan.
• Manage clinical trial activities from study start-up through close-out in accordance with regulatory and protocol requirements.
• Develop and monitor Country Operational Plans, study timelines, milestone tracking, and enrollment forecasts.
• Manage and oversee external vendors, including CROs, central laboratories, imaging vendors, and IRT providers.
• Use EDC, eTMF, CTMS, and IRT/IWRS/IVRS systems for clinical data oversight, documentation completeness, study tracking, enrollment, and investigational product management.
• Monitor and analyze time, cost, and quality performance metrics, including KPIs.
• Identify, assess, and mitigate regulatory and operational risks using RBQM principles.
• Support and coordinate regulatory submissions, including ethics committee and IRB applications and health authority communications.
• Support clinical-to-commercial transition activities to facilitate product commercialization and regulatory compliance.
• Lead or support regulatory inspections and internal audits and develop and implement CAPAs.
• Apply ALCOA+ data integrity principles to oversight of clinical trial documentation and records.
• Coordinate cross-functional teams to align with global program strategy and regulatory compliance requirements.

Benefits

• Stock
• Retirement benefits
• Medical insurance
• Life insurance
• Disability insurance
• Eligibility for an annual bonus or, for sales roles, other incentive compensation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level