Site Engagement Lead

2 months ago

Cambridge, United Kingdom Amgen Full time

Career Category

Strategy and Innovation

**Job Description**:
LIVE

What you will do

In this vital and exciting role you will be responsible for driving the development of site engagement and strategic operational partnerships with key targeted UK sites to support the delivery of Amgen’s Global Development pipeline. You will also work with cross-functional teams within Amgen to ensure there is an effective collaborative partnership with key targeted sites to support the accelerated development of marketed products and early pipeline assets.

Key Responsibilities
- 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). Locally accountable for key, targeted sites execution of clinical studies
- Primary site-facing, cross-study, operational decision-maker between Amgen and designated key sites for the purposes of establishing Amgen-Institutional operational working practices. 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.
- 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
- 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.

WIN

What we expect of you

We are seeking an individual who is able to quickly build relationships across key sites and within Amgen and implement a clear strategy to accelerate development in our mission to serve patients.
- 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)
- 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
- 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. Clinical trial management systems, reporting tools and Utilization of Key Performance Indicators (KPIs
- Various therapeutic area knowledge
- Fluency in written and spoken English

.

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