Clinical Trial Oversight Manager

Amgen

  • São Paulo - SP
  • Permanente
  • Período integral
  • Há 1 hora
Career Category ClinicalJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Clinical Trial Oversight ManagerWhat you will doLet’s do this. Let’s change the world. In this vital role you will represent the local functional management team within Global Study Operations Site Management (GSO-SM). Maintains strong collaborative partnerships with all stakeholders and ensures the overall quality of work performed by SM-FSP staff (e.g., CRAs, CTAs) supporting Amgen-sponsored clinical trials. Leads and manages contract responsibilities for both Amgen-sponsored and investigator-sponsored clinical trials. This includes managing contracts, resources, capacity planning, and performance to ensure timely and compliant trial delivery.Key Responsibilities:
  • Primary point of contact for FSP vendors for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues of Amgen clinical trials.
  • Provides support for clinical study execution, ensuring quality and timely delivery
  • Provides GSO-SM functional area expertise and actively collaborates with local and global teams in a dynamic cross-functional environment
  • Oversight of the site contracting, budgeting and payment process. Supervising, onboarding, and training the staff responsible for these processes
  • Point of escalation to support resolution of issues equality, staff turnover and performance concerns
  • Lead Functional Management Team meetings and contribute to country-level project reviews and process enhancements.
  • 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
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Clinical Trials Oversight Manager we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree ORMaster’s degree & 2 years of work experience in life sciences or medically related field, including biopharmaceutical clinical researchOrBachelor’s degree & 4 years of work experience in life sciences or medically related field, including biopharmaceutical clinical researchOrAssociate’s degree or qualified nurse (RN) & 8 years of work experience in life sciences or medically related field, including biopharmaceutical clinical researchPreferred Qualifications:
  • Clinical research experience, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting
  • Strong background in Clinical Research, including trials, ICH-GCP regulations and guidelines, site management, and roles such as CRA, CTA, or Clinical/Regional Manager.
  • Leadership in project and team management, including supervisory responsibilities.
  • Experience working with Functional Service Providers (FSPs) or Contract Research Organizations (CROs).
  • Familiarity with Quality Control functions in a biopharmaceutical setting.
  • Experience with FSP models, clinical systems, and digital tools.
  • Therapeutic area training with a focus on customer service and stakeholder communication.
  • Ability to anticipate, troubleshoot, and resolve issues effectively.
  • Excellent communication skills, with the ability to effectively engage and collaborate with cross-functional teams. Must be able to tailor messaging and communication style to suit diverse audiences.
  • Ability to work effectively in a team/matrix environment on multiple projects
  • Advanced English proficiency (written and verbal).
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now and make a lasting impact with the Amgen team. careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen 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. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..

Amgen