Job Information
Amgen Clinical Trial Oversight Manager in Tokyo, Japan
Clinical Trial Oversight Manager
Live
What you will do
Purpose
Represents local functional management team within Global Study Operations Site Management (GSO-SM)
Maintains an effective collaborative partnership with all stakeholders and assures overall quality of work performed by Functional Service Provider (FSP) staff (e.g. CRAs, CTAs) in support of Amgen sponsored clinical trials
Leads and manages contract responsibilities for Amgen sponsored and investigator sponsored clinical trials.
Responsibilities :
Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of
quality and delivery issues
Provides support of clinical study execution
Provides GSO-SM functional area expertise and actively collaborates in a dynamic cross functional environment.
Oversight of the site contracting budgeting and payment process
Line Manager of Senior Associate Clinical Contracts & Budgets (SCBA), responsible for clinical trial agreement review and approval.
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 e.g. 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.
Win
What we expect of you
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
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.
As 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.