Site Engagement Senior Manager Clinical Trials Us (Remote)

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Remote CONUS AK HI

In this vital role you will 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. You will also maintain an effective collaborative partnership with all partners, ensuring aligned and harmonious approach to site’s experience with Amgen interactions.

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).

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 partners

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 partners (medical, study management, site management, and other key -stakeholders) to drive operational efficiencies

Strong collaboration with regional and/or country Study Lead (RCTM/LCTM*) to ensure clear roles and responsibilities. Communicate cross-study lessons learned, and maintain consistent working relationships with sites

Share information and cross-study metrics to Key Stakeholders, e.g. DOM, DFM, CTOM, Study Managers etc.

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

Auto req ID

424593BR

Minimum Education Required

High School/GED

Job_Category

Pharmaceutical

Additional Qualifications/Responsibilities

Basic Qualifications:

Doctorate degree and 2 years of work experience in life sciences or medically related field OR

Master’s degree and 4 years of work experience in life sciences or medically related field OR

Bachelor’s degree and 6 years of work experience in life sciences or medically related field OR

Associate’s degree and 10 years of work experience in life sciences or medically related field OR

High school diploma / GED and 12 years of work experience in life sciences or medically related field

Preferred Qualifications

Bachelors degree

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

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)

City*

United States

State*

N/A

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen