The Clinical Trial Oversight Manager (CTOM) represents Global Study Operations Site Management (GSO-SM) and is part of the local Global Operations Management Team.
The CTOM maintains an effective collaborative partnership and assures overall quality of work performed by FSP staff (ICON / DOCS CRAs, CTAs and LMs) in support of Amgen sponsored clinical trials.
The CTOM is also the line manager for the Contracts, Budgets, and Payments (SCBA) team, locally.
Single point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, including the identification, escalation and resolution of quality and delivery issues
Provides GSO SM functional area expertise and actively collaborates in a dynamic cross-functional environment
Oversight of the site contracting process
Key Activities :
Performs oversight activities of FSP staff including CTA and CRA performance, delivery and quality metrics (KPIs, report(s) metric analysis / review) in collaboration with FSP-LM
Collaborates closely with FSP Line Manager (FSP-LM) to ensure appropriate level of oversight deployed
Supports CTA and CRA onboarding and training
Supervises staff involved in local site contracting and budget management, insurance and payment process
Point of escalation to support resolution of issues e.g. quality, staff turnover
Works with FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management
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
Leads Functional Management Team (FMT) Meetings and support applicable country-level project review meetings
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
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)
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
Knowledge of or work experience with a biopharmaceutical GRDCA or QC department
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
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
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
Ability to write and present clearly using scientific and clinical issues terminology
Attention to quality planning and execution
Amgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process.
Please contact TalentAcquisitionInquiries amgen.com to make a request and ensure you include the requisition number.
Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview .