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Site Engagement Lead Jobs
Company | Amgen |
Address | Toronto, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-16 |
Posted at | 10 months ago |
Career Category
- 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 partners, ensuring aligned and collaborative approach to site’s experience with Amgen interactions.
- Align and lead identification and strategic partnership with key sites to implement a collaborative initiative for clinical trial execution;
- Share information and cross-study metrics to Key Stakeholders, e.g. Study Managers etc.;
- Orchestrate relationship management and strong internal alignment with Amgen partners (medical, study management, site management, and other key -stakeholders) to drive operational efficiencies;
- Primary site-facing, cross-study, operational decision-maker between Amgen and designated key sites for the purposes of establishing Amgen-Institutional operational working practices;
- Locally accountable for key, targeted sites execution of clinical studies;
- Proactive and accountable to drive expansion of Amgen’s strategic relationships and meet clinical operational needs as subject matter expert;
- 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;
- 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;
- Develop, drive and monitor site operational strategies and performance across all therapeutic areas and studies, in strong collaboration with Amgen partners;
- Regular communication with key sites to connect on all trials/all stages to resolve trends and opportunities and enhance site’s experience with Amgen. On-site visits as appropriate (per site and situation);
- Participation in cross-functional task forces / process improvement groups.
- 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);
- Maintain country expertise, site knowledge to navigate with Amgen and sites with targeted and tailored communication;
- Centralize and socialize site intelligence technology, such as working practices, operational documents, to enhance clinical trial efficiencies at site;
- Strong collaboration with regional and/or country Study Lead to ensure clear roles and responsibilities. Communicate cross-study lessons learned, and maintain working relationships with sites;
- Assimilate and report external feedback to evaluate and propose operational process efficiencies, focus and direction for site collaboration on clinical trials;
- 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
- Ability to travel (Up to 30%)
- Country clinical operations experience and/or regional study management experience
- 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)
- BA/BS/BSc or RN
- Expertise and in-depth understanding of site engagement with clinical trials, or building and/or coordinating community research network
- Utilization of Key Performance Indicators (KPIs)
- M.D., D.O., PhD, PharmD, Master’s Degree
- Various therapeutic area knowledge
- Clinical trial management systems and reporting tools
- Project and Program management including oversight of quality, study results, budgets and timelines
- In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, requirements, and guidelines
- Fluency in written and spoken English
- Stock-based long-term incentives
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- Flexible work models, including remote work arrangements, where possible
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