Description
**Accountabilities**
• Develop, implement and maintain an integrated site engagement and operational role at
key/targeted sites in line with Global Development pipeline to support strategic global study
strategy plan to accelerate development of marketed products and early pipeline assets.
• Maintains an effective collaborative partnership with all stakeholders, ensuring aligned and
synergistic approach to site’s experience with Amgen interactions.
**Responsibilities**
• Leadership of Operational Site Engagement
• Align and lead identification and strategic partnership with key sites to implement a
collaborative initiative for clinical trial execution.
• Accountable for strategic long-term operational partnerships with key sites, provide local
intelligence, and contribute to maintaining a consistent and coherent voice as part of
Amgen’s overarching engagement strategy. Collaborate with other cross functional roles
for ‘tailored’ global execution of study(ies).
• Proactive and accountable to drive expansion of Amgen’s strategic relationships and
meet clinical operational needs as subject matter expert.
• Primary site-facing, cross-study, operational decision-maker between Amgen and
designated key sites for the purposes of establishing Amgen-Institutional operational
working practices.
• Maintain country expertise, site knowledge to navigate with Amgen and sites with
targeted and tailored communication.
• Develop, drive and monitor site operational strategies and performance across all
therapeutic areas and studies, in strong collaboration with Amgen stakeholders.
• Assimilate and report external feedback to evaluate and propose operational process
efficiencies, focus and direction for site collaboration on clinical trials.
• Orchestrate relationship management and strong internal alignment with Amgen
stakeholders (medical, study management, site management, and other key –
stakeholders) to drive operational efficiencies.
• Strong collaboration with Regional and/or Local Trial Manager (RCTM/LTM*) to ensure
clear roles and responsibilities. Communicate cross-study lessons learned and maintain
consistent working relationships with sites.
• Share information and cross-study KPIs to Key Stakeholders, e.g., DOM, DFM, CTOM,
Study Managers etc.
• Locally accountable for key, targeted sites execution of clinical studies
• Build and develop strong relationships with key sites to engage with Amgen as Choice
for clinical trial participation, to effectively advance site operational engagement and
better understand current site processes to enhance our clinical trial execution.
• Regular communication with key sites to connect on all trials/all stages to determine
trends and opportunities and enhance site’s experience with Amgen. On-site visits as
appropriate (per site and situation).
• Maintaining quick and direct access to key sites’ leadership & operation teams, point of
escalation for operational, cross-study potential barriers and operational issues.
• Internal point of contact to navigate working with key sites, and to help key sites navigate
working with Amgen.
• Centralize and socialize site intelligence technology, such as working practices,
operational documents, to enhance clinical trial efficiencies at site.
• Participation in cross-functional task forces / process improvement groups.
• GSO quality management
• Actively participates in role forums including local and global functional and cross functional
initiatives.
• Participates in Functional Management Team (FMT) Meetings as required and applicable
country-level project review meetings.
**Qualifications**
The knowledge and skills necessary to perform the duties of this position are
typically acquired through the following combination of education, experience
and knowledge, or the equivalent.
**Basic Qualifications**
• BA/BS/BSc or 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**
• M.D., D.O., PhD, PharmD, Master’s Degree
• Country clinical operations experience and/or regional study management
experience
• Expertise and in-depth understanding of site engagement with clinical trials, or
building and/or coordinating community research networks
**Knowledge**
• In depth understanding of drug development process, clinical trial conduct, ICH-GCP
and local regulations, requirements, and guidelines
• Project and Program management including oversight of quality, study deliverables,
budgets and timelines
• Various therapeutic area knowledge
• Fluency in written and spoken English
• Clinical trial management systems and reporting tools
• Utilization of Key Performance Indicators (KPIs)
**Competencies**
• Commitment to uphold ethics and the Amgen values
• Ability to work independently as well as in a team/matrix
environment on multiple projects and countries
• Analytical and problem solving skills
• Decision making
• Oral and written communication skills
• Strategic operational planning and cross-functional
leadership
• Horizon scanning
• Risk assessment and risk mitigation
• Issue management and escalation
• Project management
• Organizational skills: planning, time management,
prioritization, delegation
• Teamwork, collaboration and relationship building skills
across geographic areas, including: networking, negotiation
and influencing skills across all levels with both
internal/external stakeholders
• Change management skills and learning ability
• Patience, flexibility and high tolerance for ambiguity and
change.
