Clinical Trial Oversight Manager
Amgen Inc.
Mississauga, Ontario
14d ago

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.

Responsibilities :

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

Preferred Qualifications

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

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

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 .

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