Job Information
Amgen Clinical Trial Oversight Manager in Warsaw, Poland
Clinical Trial Oversight Manager in Amgen
The Clinical Trial Oversight Manager at Amgen oversees the conduct of clinical trials, ensuring they are carried out according to protocol, on time, and within budget. They liaise with various teams and external partners to ensure the quality of clinical trial data.
Responsibilities:
Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues
Provides support of clinical study execution
Provides GSO-SM functional area expertise and actively collaborates in a dynamic crossfunctional environment
Oversight of the site contracting, budgeting and payment process
Basic Qualifications
Doctorate degree OR
Master’s degree OR
BA/BS/BSc or qualified nurse (RN)
Work 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)
Preferred Qualifications
Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry
Experience in a project leadership role
Experience working with or for Functional Service Provider or Contract Research Organizations
Supervisory Experience
Knowledge of or work experience with a biopharmaceutical GRDCA or QC department
Knowledge
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
Computer and system operation skills
Relevant therapeutic area education and training
Detailed understanding of customer service
Demonstrated ability to anticipate and resolve problems
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, or disability status.
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