**Join Amgen's Mission of Serving Patients**:
At Amgen, if you feel like you are 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 ****, 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.
We have proudly achieved certifications as **Great Place to Work and Equidad MX**.
Join us and transform the lives of patients while transforming your career.
**Clinical Trial Oversight Manager (CTOM)**
**Key responsibilities include, but are not limited to**:
- Performs sponsor oversight activities of SM-FSP, including staff performance (indicators, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.
- Collaborates closely with SM-FSP Line Manager (FSPLM) to ensure an appropriate level of their staff oversight is deployed.
- Supports SM-FSP staff onboarding and training.
- Supervises staff involved in local site contracting and budget management, insurance and payment process.
- Manages SCBA onboarding and training.
- Point of escalation for all interested parties to support resolution of issues e.g. quality, staff turnover and performance concerns.
- Works with SM-FSP vendor(s)



to ensure timely and appropriate planning, resource and capacity management from study start up to close-out.
- Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships.
- Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution.
- Organizes and owns the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.
- To be involved in local and integral site management and cross functional interested party collaboration.
- Actively participates in role forums including local and global functional and cross-functional initiatives.
**What we expect from you**:
We are all different, yet we all use our unique contributions to serve patients.
Familiarity with advanced concepts of clinical research, extensive knowledge of ICH/GCP regulations and guidelines, strong knowledge of clinical trial operations, understanding of Functional Service Provider operational model, demonstrated ability to work independently with mínimal supervision, ability to work effectively in a team/matrix environment on multiple projects, excellence in relationship building, ability to lead and influence in a positive manner (strong leadership skills), strong interpersonal skills, excellent organizational and planning skills,



excellent oral and written communication ( Business English fluency).
The professional we seek has these qualifications below.
**Basic Qualifications**:
- Doctorate degree and experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) or
- Master's degree and 2 years of experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) or
- Bachelor's degree BA/BS/BSc or qualified nurse (RN) and 4 years of experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) or
- Associate's degree and 8 years of experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) or
- High school diploma / GED and 10 years of experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
- Business English fluency.
**Preferred Qualifications**:
- Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry.
- Exp

📌 Clinical Trial Oversight Manager (Ctom) (Xico)
🏢 Amgen
📍 Xico