Site Engagement Sr Mgr

<h2><b>Career Category</b></h2>Clinical<h2></h2><h2><b>Job Description</b></h2><p><u><b>Accountabilities</b></u><br />• Develop, implement and maintain an integrated site engagement and operational role at<br />key/targeted sites in line with Global Development pipeline to support strategic global study<br />strategy plan to accelerate development of marketed products and early pipeline assets.<br />• Maintains an effective collaborative partnership with all stakeholders, ensuring aligned and<br />synergistic approach to site’s experience with Amgen interactions.<br /><u><b>Responsibilities</b></u><br />• Leadership of Operational Site Engagement<br />• Align and lead identification and strategic partnership with key sites to implement a<br />collaborative initiative for clinical trial execution.<br />• Accountable for strategic long-term operational partnerships with key sites, provide local<br />intelligence, and contribute to maintaining a consistent and coherent voice as part of<br />Amgen’s overarching engagement strategy. Collaborate with other cross functional roles<br />for ‘tailored’ global execution of study(ies).<br />• Proactive and accountable to drive expansion of Amgen’s strategic relationships and<br />meet clinical operational needs as subject matter expert.<br />• Primary site-facing, cross-study, operational decision-maker between Amgen and<br />designated key sites for the purposes of establishing Amgen-Institutional operational<br />working practices.<br />• Maintain country expertise, site knowledge to navigate with Amgen and sites with<br />targeted and tailored communication.<br />• Develop, drive and monitor site operational strategies and performance across all<br />therapeutic areas and studies, in strong collaboration with Amgen stakeholders.<br />• Assimilate and report external feedback to evaluate and propose operational process<br />efficiencies, focus and direction for site collaboration on clinical trials.<br />• Orchestrate relationship management and strong internal alignment with Amgen<br />stakeholders (medical, study management, site management, and other key -<br />stakeholders) to drive operational efficiencies.<br />• Strong collaboration with Regional and/or Local Trial Manager (RCTM/LTM*) to ensure<br />clear roles and responsibilities. Communicate cross-study lessons learned and maintain<br />consistent working relationships with sites.<br />• Share information and cross-study KPIs to Key Stakeholders, e.g., DOM, DFM, CTOM,<br />Study Managers etc.<br />• Locally accountable for key, targeted sites execution of clinical studies<br />• Build and develop strong relationships with key sites to engage with Amgen as Choice<br />for clinical trial participation, to effectively advance site operational engagement and<br />better understand current site processes to enhance our clinical trial execution.<br />• Regular communication with key sites to connect on all trials/all stages to determine<br />trends and opportunities and enhance site’s experience with Amgen. On-site visits as<br />appropriate (per site and situation).<br />• Maintaining quick and direct access to key sites’ leadership &amp; operation teams, point of<br />escalation for operational, cross-study potential barriers and operational issues.<br />• Internal point of contact to navigate working with key sites, and to help key sites navigate<br />working with Amgen.<br />• Centralize and socialize site intelligence technology, such as working practices,<br />operational documents, to enhance clinical trial efficiencies at site.<br />• Participation in cross-functional task forces / process improvement groups.<br />• GSO quality management<br />• Actively participates in role forums including local and global functional and cross functional<br />initiatives.<br />• Participates in Functional Management Team (FMT) Meetings as required and applicable<br />country-level project review meetings.</p><p></p><p><u><b>Qualifications</b></u><br />The knowledge and skills necessary to perform the duties of this position are<br />typically acquired through the following combination of education, experience<br />and knowledge, or the equivalent.<br /><b>Basic Qualifications</b><br />• BA/BS/BSc or RN<br />• Work experience in life sciences or medically related field,<br />including biopharmaceutical clinical research experience (clinical research obtained<br />working on clinical trials in a biotech, pharmaceutical or CRO company, or other<br />relevant clinical setting)<br /><b>Preferred Qualifications</b><br />• M.D., D.O., PhD, PharmD, Master’s Degree<br />• Country clinical operations experience and/or regional study management<br />experience<br />• Expertise and in-depth understanding of site engagement with clinical trials, or<br />building and/or coordinating community research networks<br /><b>Knowledge</b><br />• In depth understanding of drug development process, clinical trial conduct, ICH-GCP<br />and local regulations, requirements, and guidelines<br />• Project and Program management including oversight of quality, study deliverables,<br />budgets and timelines<br />• Various therapeutic area knowledge<br />• Fluency in written and spoken English<br />• Clinical trial management systems and reporting tools<br />• Utilization of Key Performance Indicators (KPIs)</p><p><u><b>Competencies</b></u><br />• Commitment to uphold ethics and the Amgen values<br />• Ability to work independently as well as in a team/matrix<br />environment on multiple projects and countries<br />• Analytical and problem solving skills<br />• Decision making<br />• Oral and written communication skills<br />• Strategic operational planning and cross-functional<br />leadership<br />• Horizon scanning<br />• Risk assessment and risk mitigation<br />• Issue management and escalation<br />• Project management<br />• Organizational skills: planning, time management,<br />prioritization, delegation<br />• Teamwork, collaboration and relationship building skills<br />across geographic areas, including: networking, negotiation<br />and influencing skills across all levels with both<br />internal/external stakeholders<br />• Change management skills and learning ability<br />• Patience, flexibility and high tolerance for ambiguity and<br />change.</p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.