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Clinical Trial Oversight Manager
hace 2 semanas
**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 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. 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 global 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
