Clinical Trial Oversight Manager

1 tydzień temu

Warszawa, Mazovia, Polska Amgen SA Pełny etat
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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