Site Engagement Sr Mgr
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Salary Not Disclosed
1 Vacancy
Job Description
Career Category
ClinicalJob 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 sites 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
Amgens overarching engagement strategy. Collaborate with other cross functional roles
for tailored global execution of study(ies).
Proactive and accountable to drive expansion of Amgens 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 sites 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 Masters 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.
Required Experience:
Manager
Employment Type
Full-Time
