Local Trial Manager - Thousand Oaks, CA

Local Trial Manager

Thousand Oaks, CA

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives 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.

What You Will Do And What We Expect Of You

In this vital role you will :

• 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
• Assign and deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan

May telecommute.

Additional Qualifications / Responsibilities

Requirements : Master's degree (or foreign equivalent) in Drug Regulatory Affairs, Biology, Chemistry or related field & 3 years of experience in the following :

Job type : Full Time position. The annual salary range for this position in the U.S. is $126,432.00 - $144,987.00 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 :