Clinical Trial Site Engagement Sr Manager
hace 3 semanas
Career Category
Clinical
**Job Description**:
Clinical Trial Site Engagement Sr Manager
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. 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 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(is).-
- 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 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.- Share information and cross-study KPIs to Key Stakeholders, e.g., DOM, DFM, CTOM, Study Managers etc.
Locally accountable for key, targeted sites execution of clinical studies- 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.
GSO quality management- Actively participates in role forums including local and global functional and cross functional initiatives.- Participates in Functional Management Team (FMT) Meetings as required and applicable country-level project review meetings.
Minimum Requirements
Basic Qualifications- Minimum 6 years’ experience in clinical research in a role that oversees (project/clinical operations management)- 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)- Availability for travel (~60% of the time)- Fluent English
Preferred Qualifications- M.D., D.O., PhD, PharmD, Master’s Degree- 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
Skills & 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)
Competencies- Commitment to uphold ethics and the 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 pl
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