Clinical Trial Oversight Manager

Amgen Inc.

3.6

(9)

Multiple Locations

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-182437

    Position summary

    functional environment

    • Oversight of the site contracting, budgeting and payment process

    • Line Manager of SCBAs

    Key Activities:

    • Performs sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.

    • Collaborates closely with SM-FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed.

    • Supports SM-FSP staff onboarding and training

    • Supervises staff involved in local site contracting and budget management, insurance and payment process

    • Manages SCBA onboarding and training

    • Point of escalation for all stakeholders to support resolution of issues eg quality, staff turnover and performance concerns

    • Works with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out

    • Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships

    • Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution

    • Organizes and leads the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.

    • Involved in local and global site management and cross-functional stakeholder collaboration

    • Actively participates in role forums including local and global functional and cross-functional initiatives

    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

    Competencies:

    • Demonstrated ability to work independently with minimal supervision

    • Ability to work effectively in a team/matrix environment on multiple projects

    • Excellence in relationship building

    • Ability to lead and influence in a positive manner

    • Leadership

    • Strong interpersonal skills

    • Excellent organizational and planning skills

    • Excellent oral and written communication

    • Language: Business English fluency

    • Attention to quality and detail

    • Ability to identify and resolve problems

    • Flexibility

    • Ability to write and present clearly using scientific and clinical issues terminology

    • Attention to quality planning and execution

    • Ability for critical thinking and thinking out of the box

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging