Global Clinical Program Management Sr. Manager – Observational Research (US based) @Amgen

Job Information

Job Description:

Responsible for:

  • Oversee people management, career development, training and succession planning of Amgen GTMs supporting the Observational Research Portfolio
  • Support CPO resource planning for Observational Research portfolio in collaboration with CPO/OR Director, PRM and FSP Partners.
  • Oversee the operational execution, design, planning, risk assessment and mitigations of assigned observational research (OR) studies
  • Oversight of assigned OR study budgets including change control in collaboration with TA Governance and Finance.
  • Ensure strong relationships and alignment with TA, GSO, CfOR, Safety, and HE representatives, maintaining and improving global collaboration and consistency
  • Providing clinical operations leadership and expertise on the Product Teams (PTs) Key Evidence Generation Teams (KEGs) and Evidence Generation Teams (EGTs) as requested.
  • Support the identification of outsourcing requirements and oversee the evaluation, selection, setup, and management of vendors for observational studies
  • Contribute operational expertise ensuring operational feasibility throughout study design process, including KDE and Protocol Development.
  • Provide advice as requested on core study documents prior to Governance Body review.
  • Lead the Country Operational Landscape Assessments and study feasibility with Feasibility Director (study level)
  • Oversee and approve study global enrollment baselines and accurate global recruitment forecasting
  • Support fit for purpose OR operating model by identifying process gaps or improvements with the development of new processes, authoring. Review of SOPs, Work Instructions, FORMS, templates and training.
  • Support and coordinate audit and inspection activities and contributes to CAPAs ensuring the update of processes where vital and appropriate verifications.
  • Communicate effectively with key team members to ensure operational strategy alignment and contribute to functional goal setting within the program.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a driven individual with these qualifications.

Basic Qualifications:

  • Doctorate degree & 2 years of life sciences or medically related field OR
  • Master’s degree & 6 years of life sciences or medically related field OR
  • Bachelor’s degree & 8 years of life sciences or medically related field OR
  • Associate’s degree & 10 years of life sciences or medically related field OR
  • High school diploma / GED & 12 years of life sciences or medically related field AND
  • 2 years of direct managerial and/or leadership experience

Preferred Qualifications:

  • BS/BA/BSc in the sciences or RN
  • 9 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
  • Experience conducting and/or overseeing observational research execution in an industry setting
  • Previous management experience of direct reports
  • Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc)
  • Experience driving and leading process development and /or improvement

Experience Level: Senior
Work From: Remote from Country

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