Clinical Trial Site Engagement Sr Manager

Clinical Trial Site Engagement Sr Manager Amgen Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with the 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. 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 maintain a consistent voice as part of Amgen’s overarching engagement strategy. Collaborate with cross‑functional roles for tailored global execution of studies. Primary site‑facing, cross‑study, operational decision‑maker between Amgen and designated key sites for establishing Amgen‑institutional operational working practices. Maintain country expertise and site knowledge to navigate with Amgen and sites with targeted communication. 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 for site collaboration on clinical trials. 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 (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 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 Amgen as a choice for clinical trial participation and enhance site operational engagement. Regularly communicate with key sites on all trials and stages to identify trends, opportunities, and improve site experience with Amgen. Conduct on‑site visits as appropriate to foster quick, direct access to key site leadership and operations teams. Function as point of escalation for operational, cross‑study barriers and issues. Centralize and socialize site intelligence technology (working practices, operational documents) to enhance clinical trial efficiencies. Participate in cross‑functional task forces and process improvement groups. GSO Quality Management Actively participate in role forums, including local and global functional initiatives. Attend Functional Management Team (FMT) meetings and relevant country‑level project review meetings. Minimum Requirements Basic Qualifications Minimum 6 years’ experience in clinical research overseeing project/clinical operations management. Work experience in life sciences or medically related field (biopharmaceutical, CRO, or other relevant clinical setting). Availability for travel (~60% of the time). Fluent in English. Preferred Qualifications M.D., D.O., PhD, PharmD, or Master’s Degree. Country clinical operations experience and/or regional study management experience. Expertise in site engagement with clinical trials or building and coordinating community research networks. Skills & Knowledge In‑depth understanding of drug development process, clinical trial conduct, ICH‑GCP and local regulations. Project and program management skills, including quality oversight, study deliverables, budgets, and timelines. Knowledge of various therapeutic areas. Fluency in written and spoken English. Experience with clinical trial management systems and reporting tools. Utilization of key performance indicators (KPIs). Competencies Commitment to uphold ethics and Amgen values. Ability to work independently and in a team/matrix environment on multiple projects and countries. Strong analytical and problem‑solving skills. Decisiveness. Excellent oral and written communication skills. Strategic operational mindset. Sr. Clinical Trial Coordinator Thermo Fisher Scientific Work Schedule: Standard (Mon‑Fri) Environmental Conditions: Office According to the specific role (Central or Local), coordinates, oversees, and completes functions on assigned trial activities detailed in the task matrix. Performs department, internal, country, and investigator‑level functions aligned with assigned trial responsibilities. Study Start Up Associate I/ii/sr At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as a team. #J-18808-Ljbffr