Local Trial Manager

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybride; USD 138 000 - 164 000; Plein temps

Avantages offerts par ce poste

Stock plan

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus

Résumé du poste

Amgen is seeking a Local Trial Manager to lead country-level delivery of clinical studies. Responsibilities include data processing, SOP adherence, and coordinating with global teams to drive study progress. The role requires a Master’s degree in a related field and 3 years of trial-related experience.

The candidate will support regulatory submissions, audits, and CAPA development, while overseeing EDC, eTMF, CTMS, and IRT systems within a flexible work model including remote arrangements.

Qualifications

• Master’s degree in Drug Regulatory Affairs, Biology, Chemistry or related field and 3 years of experience in clinical trials.
• Experience applying ICH E6 (R2) GCP and FDA regulations in global trials.
• Experience managing trials from start-up to close-out with COPs, timelines and enrollment forecasting.
• Experience with CROs, central labs, imaging vendors and IRT providers.
• Familiarity with EDC, eTMF, CTMS, and IRT/IWRS/IVRS systems.
• Ability to coordinate cross-functional teams and ensure regulatory compliance.

Responsabilités

• Process and manage clinical data and documentation; ensure SOP compliance.
• Coordinate country-level strategies and study delivery with local teams.
• Support regulatory submissions and inspections; drive CAPA resolution.
• Lead or support cross-functional country operational plans and timelines.
• Monitor KPIs, time, cost, and quality metrics for trial progress.

Connaissances

GCP E6 (R2)

FDA regulations

Cross-functional lead

RBQM principles

Risk management

Data integrity (ALCOA+)

CTMS oversight

EDC systems (Medidata Rave)

eTMF systems (Veeva Vault TMF)

Regulatory submissions

Formation

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

Outils

Medidata Rave

Veeva Vault TMF

CTMS

IRT/IWRS/IVRS systems

Description du poste

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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

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. The position requires 3 years of experience in the following:

• 1. Applying ICH E6 (R2) Good Clinical Practice (GCP) and related ICH guidelines in the management of global clinical trials;
• 2. Interpreting and implementing FDA regulations (21 CFR Parts 11, 50, 54, 56, and 312) and other applicable regulatory requirements in clinical trial execution;
• 3. Managing clinical trial activities from study start-up through close-out in accordance with regulatory and protocol requirements;
• 4. Developing and monitoring Country Operational Plans (COPs), study timelines, milestone tracking, and enrollment forecasting;
• 5. Managing and oversee external vendors, including Clinical Research Organizations (CROs), central laboratories, imaging vendors, and IRT providers;
• 6. Utilizing Electronic Data Capture (EDC) systems including Medidata Rave for clinical data oversight and monitoring;
• 7. Utilizing Electronic Trial Master File (eTMF) systems including Veeva Vault TMF to ensure documentation completeness and inspection readiness;
• 8. Utilizing Clinical Trial Management Systems (CTMS) to track study progress, budgets, and performance metrics;
• 9. Overseeing Interactive Response Technology (IRT/IWRS/IVRS) systems for enrollment tracking and investigational product management;
• 10. Monitoring and analyzing time, cost, and quality performance metrics, including Key Performance Indicators (KPIs);
• 11. Identifying, assessing, and mitigating regulatory and operational risks using risk-based quality management (RBQM) principles;
• 12. 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;
• 13. Leading or supporting regulatory inspections, internal audits, and CAPA development and implementation;
• 14. Applying data integrity principles including ALCOA+ in oversight of clinical trial documentation and records;
• 15. 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. For more details visit https://careers.amgen.com/life-at-amgen/benefits/

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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

careers.amgen.com

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 does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.