Local Trial Manager

Amgen • Thousand Oaks, CA

114d • $157,435 • Remote

About The Position

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.

Requirements

• Master's degree (or foreign equivalent) in Nursing or related field.
• 2 years of experience involving site selection and accountable for site-level goal setting and study-specific deliverables for clinical sites within their country.
• Monitoring the execution of the clinical study against timelines, deliverables, and budget.
• Providing input into and leading the development of study-specific plans including case report forms, data management plans, monitoring plans and other documents.
• Overseeing the quality and scientific integrity of clinical operations for studies.
• Communicating study status including timelines and deliverables to key stakeholders such as clinical study team, program managers, therapeutic area heads, or global development leads, and overseeing updates to relevant systems.
• Overseeing timely electronic case report form (eCRF) completion, query resolution, site-close out activities and activities of other contributing functional areas including data management, biostatistician, or safety.
• Leading, managing and coordinating the conduct of clinical trials from study start-up to study close out at a country level in accordance with ICH Guideline for Good Clinical Practice (GCP) and other applicable local regulations.

Responsibilities

• Communicate country status including timelines and deliverables to key partners including updates to relevant systems for transparency.
• Accountable for site-level goal setting and study specific deliverables for clinical sites within their countries.
• Manage, oversee and supervise applicable vendor activities such as laboratories and equipment provisioning.
• Contribute and develop program and study-specific materials such as monitoring plan, study specific training documents.
• Support and contribute to Clinical Study Teams or Trial Management Teams.
• Partner with global and local country teams to provide high level country strategy and actively drive study progress and local and country level study delivery.
• Provide planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team.
• Utilize local and country regulatory knowledge to contribute to non-Amgen medicine product provisioning and import and export license processes.

Benefits

• Stock options
• Retirement plan
• Medical insurance
• Life insurance
• Disability insurance
• Eligibility for an annual bonus or for sales roles, other incentive compensation
• Comprehensive employee benefits package
• Flexible work models, including remote and hybrid work arrangements

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Master's degree