Job Description

Role Description

Join Amgen’s Mission of Serving Patients. In this vital role, you will manage Clinical Data Management (CDM) activities within and across projects within the biosimilars operational unit in partnership with a CRO in a fully outsourced business model. You will lead CDM function and system integrations at Amgen and CROs/external partners to ensure timely study data delivery.

• Management of biosimilars CDM activities and program(s), including system infrastructure and integration and maintenance of SharePoint site permissions and content.
• Input into group goals and objectives.
• Implementing CDM strategies and assisting in implementation of wider biosimilar goals and strategies.
• Assisting with development of, reviewing, implementing and enforcing biosimilars SOPs.
• Ensuring delivery of quality clinical trial data, within agreed upon timelines.
• Ensuring CDM processes/systems meet regulatory and business requirements.
• Assist with CRO contracts and budgets.

Qualifications

• Doctorate degree and 2 years of clinical data management experience OR
• Master’s degree and 4 years of clinical data management experience OR
• Bachelor’s degree and 6 years clinical data management experience OR
• Associate’s degree and 10 years of clinical data management experience OR
• High school diploma / GED and 12 years of clinical data management experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Requirements

• Master's degree or equivalent in life science, computer science, business administration or related discipline.
• 10 years of work experience in data management in the Pharmaceutical or Biotech arena.
• 3+ years of experience in a global organization.
• Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.).

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Company Description

Amgen is dedicated to improving the quality of life for people around the world and 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.

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