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.

• 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

• Line Manager of SCBAs