Local Trial Manager

Amgen; Thousand Oaks (CA); Presencial; USD 138 000 - 164 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Stock-based long-term incentives

Retirement plan and benefits

Flexible work arrangements

Resumo da oferta

Amgen in Thousand Oaks, CA is seeking a Local Trial Manager to oversee country-level trial delivery, plan study execution, and coordinate cross-functional teams across global programs.

You will manage country operational plans, ensure regulatory compliance, monitor KPIs, and support inspections, with potential telecommuting.

Qualificações

• Master’s degree in Drug Regulatory Affairs, Biology, Chemistry or related field.
• Applying ICH E6 (R2) GCP and related ICH guidelines in global trials.
• Interpreting FDA regulations in clinical trial execution.
• Managing clinical trial activities from start-up to close-out.
• Developing and monitoring COPs, timelines and enrollment forecasts.
• Overseeing CROs, central labs, imaging vendors, and IRT providers.
• Using Medidata Rave, Veeva Vault TMF and CTMS for oversight.
• RBQM principles for risk-based quality management.

Responsabilidades

• Plan, manage and oversee the clinical study implementation.
• Provide country-level input into COPs and study timelines.
• Coordinate cross-functional teams to align with global strategy.
• Support regulatory submissions and inspections; CAPA development.
• Monitor KPIs, costs, and timelines for study progress.
• Lead or support regulatory inspections and audits.
• Ensure documentation integrity and inspection readiness.

Conhecimentos

ICH E6 GCP

Clinical trial management

Regulatory knowledge

Cross-functional collaboration

Risk-based quality management

Formação académica

Master’s degree in Drug Regulatory Affairs, Biology, Chemistry or related field

Ferramentas

Medidata Rave

Veeva Vault TMF

CTMS

EDC systems

Descrição da oferta de emprego

Local Trial Manager Duties:

Process clinical data, including receipt, entry, verification, or filing of information; Monitor work productivity or quality to ensure compliance with standard operating procedures; Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or 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 to provide high level country strategy and actively drive study progress and local/country level study delivery; Plan, manage and oversee the clinical study implementation in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team; Communication country status (including timelines and results) to key partners including updated to relevant systems for transparency; Provide country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study; Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate; and Assign and deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan. May telecommute.

Requirements:

1. Master’s degree (or foreign equivalent) in Drug Regulatory Affairs, Biology, Chemistry or related field & 3 years of experience in the job offered or in clinical trial-related occupation.
2. Applying ICH E6 (R2) Good Clinical Practice (GCP) and related ICH guidelines in the management of global clinical trials.
3. Interpreting and implementing FDA regulations (21 CFR Parts 11, 50, 54, 56, and 312) and other applicable regulatory requirements in clinical trial execution.
4. Managing clinical trial activities from study start-up through close-out in accordance with regulatory and protocol requirements.
5. Developing and monitoring Country Operational Plans (COPs), study timelines, milestone tracking, and enrollment forecasting.
6. Managing and oversee external vendors, including Clinical Research Organizations (CROs), central laboratories, imaging vendors, and IRT providers.
7. Utilizing Electronic Data Capture (EDC) systems including Medidata Rave for clinical data oversight and monitoring.
8. Utilizing Electronic Trial Master File (eTMF) systems including Veeva Vault TMF to ensure documentation completeness and inspection readiness.
9. Utilizing Clinical Trial Management Systems (CTMS) to track study progress, budgets, and performance metrics.
10. Overseeing Interactive Response Technology (IRT/IWRS/IVRS) systems for enrollment tracking and investigational product management.
11. Monitoring and analyzing time, cost, and quality performance metrics, including Key Performance Indicators (KPIs).
12. Identifying, assessing, and mitigating regulatory and operational risks using risk-based quality management (RBQM) principles.
13. Supporting and coordinating regulatory submissions, including ethics committee, IRB applications, health authority communications, and Supporting clinical-to-commercial transition activities to facilitate product commercialization and regulatory compliance.
14. Leading or supporting regulatory inspections, internal audits, and CAPA development and implementation.
15. Applying data integrity principles including ALCOA+ in oversight of clinical trial documentation and records.
16. Coordinating cross-functional teams to ensure alignment with global program strategy and regulatory compliance requirements.

Job type: Full-Time position.

The annual salary range for this position in the U.S. is $138,320.00 - $163,992.00 per year.

Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation.

What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.