Clinical trial oversight manager

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 CRO staff (eg CRAs, CTAs) in support of Amgen sponsored clinical trials

• Leads and manages contract responsibilities for Amgen sponsored and investigator sponsored clinical trials.

Key activities:

• Performs sponsor oversight activities of FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.

• Collaborates closely with FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed.

• Supports FSP staff onboarding and training

• Supervises staff involved in local site contracting and budget management, insurance and payment process

• Manages Site Contracting and Budget Associate (SCBA) onboarding and training

• Point of escalation for all stakeholders to support resolution of issues eg quality, staff turnover and performance concerns

• Works with 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 crossfunctional stakeholder collaboration

• Actively participates in role forums including local and global functional and cross-functional initiatives

Basic qualifications:

• Master’s degree OR

• BA/BS/BSc or qualified nurse (RN)

• Minimum of 12 years of 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 & People managing

• Knowledge of or work experience with 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