Local Trial Manager

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.

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.

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…