Clinical Trial Oversight Manager (CTOM)

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like you are part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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 minimal 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
• Masters 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
• Bachelors 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
• Associates 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.
• Experience in a project leadership role working with or for Functional Service Provider or Contract Research Organizations.
• Knowledge of or work experience with a biopharmaceutical GRDCA or QC department.
• Proven ability to work independently with minimal direction and work optimally in a team/matrix environment on multiple projects.

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 well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.