Amgen Clinical Trial Oversight Manager / Development Feasibility Manager in Hong Kong, Hong Kong

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

Management of local feasibility

Inform on country capability

Drive Targeted local feasibility

Deliver local information into study design planning

Develop local strategy for operational plan

Drive Voice of Patient and Voice of Site data collection, as applicable

Drive local patient recruitment and retention strategies

Partner with Global Feasibility Operations Director

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

Supports CTA and CRA onboarding and training

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

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

Participates in Functional Management Team (FMT) Meetings and applicable country-level project review meetings

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

Build internal/external stakeholder engagement aiming at identifying new investigators and maintaining relationship with and knowledge of current investigators in alignment with Amgen's product clinical development plans.

Develop repository of local site intelligence information (Country Landscaping) to support operational delivery

Identify and contract with Reference Sites in support of local landscaping

Understand local outreach and patient referral pathways in support of global/local operational delivery

Develop and maintain knowledge of external local clinical trial environment and assess developments for impact on study design and execution

Partner with Global Feasibility Operations Director (GFOD) and Development Design Center (DDC) to provide local country landscaping data for inclusion in the Evidence Generation Plan and study design as applicable

Engage with local reference sites to obtain input on proposed study design (Study Design Optimization) as requested by GFOD/DDC and partner with GFOD to analyselocal feedback for incorporation into study design and operational planning decisions

Support operating reviews by monitoring predictability and delivery, and perform refinements required to local site intelligence data\

Use site intelligence and local cross-functional input for study-level operational planning in support of validation of country commitment for a study

Ensure consistency of activities and development of best practices through leadership

Basic Qualifications

BA/BS/BSc or qualified nurse (RN)

Work experience working in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience 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

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

Operational performance measurement experience

International collaboration experience

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