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 SM-FSP staff (eg 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 SCBAs

Key activities include but are not limited to

• 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 eg 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

Key Relationships: (excluding Direct Line relationships)

• SM-FSP Management
• Local Operating Country Staff
• Global Clinical Program Management
• R&D Compliance and Audit
• Global Development Operations Stakeholders
• Investigator Site Staff
• Global Supplier Governance
• Innovation Planning & Platform Services

Decision Making Authority:

• Financial sign off within grade parameters
• Risk mitigation, issue management and escalations
• Hiring and performance management where applicable

Outputs:

• Reporting on quality (e.g., Site Quality Visits (SQV), monthly line manager reporting) and delivery and adherence to Quality Oversight Plan and country timelines and commitments.
• Key performance Indicator (KPI) and scorecard review
• Resource, planning and capacity management
• Process analysis, improvement and global alignment.

Qualifications

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