Clinical Trial Oversight Manager

7 giorni fa

Milano, Lombardia, Italia Amgen Inc. (Ir) A tempo pieno

Clinical Trial Oversight Manager

This role is responsible for performing sponsor oversight activities of SM-FSP, including staff performance, to ensure quality and delivery of Amgen clinical trials. The successful candidate will collaborate closely with SM-FSP Line Manager to ensure appropriate level of staff oversight is deployed.

Key Responsibilities:

  • Perform sponsor oversight activities of SM-FSP, including staff performance, to ensure quality and delivery of Amgen clinical trials.
  • Collaborate closely with SM-FSP Line Manager to ensure appropriate level of staff oversight is deployed.
  • Support SM-FSP staff onboarding and training.
  • Supervise staff involved in local site contracting and budget management, insurance, and payment process.
  • Manage SCBA onboarding and training.
  • Act as point of escalation for all stakeholders to support resolution of issues on quality, staff turnover, and performance concerns.
  • Work with SM-FSP vendor(s) to ensure timely and appropriate planning, resource, and capacity management from study start-up to close-out.
  • Conduct on-site quality visits with CRAs where/when appropriate and support the maintenance of Amgen investigator site relationships.
  • Support inspection readiness, local country and site level audits, and regulatory inspections when applicable including CAPA resolution.
  • Organize and lead the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.
  • Be involved in local and global site management and cross-functional stakeholder collaboration.
  • Actively participate in role forums including local and global functional and cross-functional initiatives.

Requirements:

  • 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
  • Broad work experience working in life sciences or medically related field, including clinical site management experience
  • 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 and Competencies Clinical Research: Familiarity with advanced concepts of clinical research, extensive knowledge of ICH/GCP regulations and guidelines, strong knowledge of clinical trial operations, and understanding of Functional Service Provider operational model
  • Technical Skills: Computer and system operation skills
  • Therapeutic Area: Relevant therapeutic area education and training
  • Customer Service: Detailed understanding of customer service and demonstrated ability to anticipate and resolve problems
  • Independence & Teamwork: Demonstrated ability to work independently with minimal supervision and effectively in a team/matrix environment on multiple projects
  • Leadership & Influence: Excellence in relationship building, ability to lead and influence in a positive manner, and strong leadership skills
  • Interpersonal & Communication Skills: Strong interpersonal skills, excellent organizational and planning skills, excellent oral and written communication, and business English fluency
  • Quality & Detail: Attention to quality and detail, ability to identify and resolve problems, and attention to quality planning and execution
  • Problem Solving & Flexibility: Ability for critical thinking, thinking out of the box, and flexibility
  • Scientific Communication: Ability to write and present clearly using scientific and clinical issues terminology

About Us:

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

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