Site Engagement Sr Mgr

Accountabilities

• Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with the Global Development pipeline to support the strategic global study plan. This accelerates the development of marketed products and early‑pipeline assets.
• Maintain an effective collaborative partnership with all stakeholders, ensuring a synergistic approach to the site experience and Amgen interactions.

• Lead operational site engagement initiatives.
• Identify and lead strategic partnerships with key sites to implement collaborative initiatives for clinical‑trial execution.
• Accountable for strategic long‑term operational partnerships, providing local intelligence and maintaining a coherent voice as part of Amgen’s overarching engagement strategy.
• Collaborate with cross‑functional roles for tailored global execution of studies.
• Drive expansion of Amgen’s strategic relationships to meet clinical operational needs as a subject‑matter expert.
• Serve as the primary site‑facing, cross‑study operational decision‑maker between Amgen and designated key sites.
• Maintain country expertise and site knowledge to tailor communications with Amgen and sites.
• Develop, drive and monitor site operational strategies and performance across all therapeutic areas and studies in collaboration with Amgen stakeholders.
• Assimilate and report external feedback to evaluate and propose operational process efficiencies.
• Orchestrate relationship management and internal alignment with Amgen stakeholders (medical, study management, site management, and other key stakeholders) to drive operational efficiencies.
• Collaborate with Regional and/or Local Trial Manager to ensure clear roles and responsibilities, communicating cross‑study lessons learned.
• Share information and cross‑study KPIs with key stakeholders such as DOM, DFM, CTOM, and Study Managers.
• Locally accountable for key, targeted sites’ execution of clinical studies.
• Build and develop strong relationships with key sites to engage them as Amgen’s preferred partners for clinical trial participation.
• Maintain regular communication with key sites to determine trends, opportunities and enhance the site experience with Amgen; conduct on‑site visits as appropriate.
• Provide quick and direct access to key sites’ leadership & operation teams for escalation and resolution of operational issues.
• Act as the internal point of contact for navigating working practices with key sites.
• Centralize and socialize site intelligence technology and operational documents to enhance clinical trial efficiencies.
• Participate in cross‑functional task forces and process improvement groups.
• Manage GSO quality, and actively participate in role forums, functional and global initiatives.
• Participate in Functional Management Team (FMT) Meetings and country‑level project reviews as required.

• 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).

• MD, DOI, PhD, Pharm
  
  D, Master’s Degree.
• Country‑level clinical operations experience and/or regional study management.

• Expertise and in‑depth understanding of site engagement in 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.
• Various therapeutic area knowledge.
• Fluency in written and spoken English.
• Clinical trial management systems and reporting tools.
• Utilization of key performance indicators (KPIs).

• Commitment to uphold ethics and 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 at all levels.
• Change management skills and learning ability.
• Patience, flexibility and high tolerance for ambiguity and change.

Not Applicable

Full‑time

Research and Science

Biotechnology Research and Pharmaceutical Manufacturing