Site Engagement Liaison

hace 1 semana


En remoto, España ICON A tiempo completo

As a Site Engagement Liaison you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

**What you will be doing**:

- Responsible for site and monitoring quality, regulatory and GCP compliance.
- Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution.
- Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
- Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks. Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.
- Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.). Demonstrate use of data to enhance quality and accelerate study delivery.
- Conduct and report oversight activities, both remote and onsite visits, according to Pfizer requirements and standards.
- Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs. These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).
- Work with Provider CRAs, and other Provider colleagues as appropriate, to drive resolution of oversight issues.
- Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these.
- Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery.
- Identify potential improvements for Pfizer processes.
- Review of monitoring visit reports.

**Protocol Site Oversight**
- Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.
- Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.

**Site and Study Management Interface**
- Support local Investigator relationship management with the Site Relationship Partner.
- Serve as point of contact for quality and safety escalations for Provider, CRAs, Site Relationship Partner and Study Team.
- Support the resolution of operational obstacles at the site/country level in order to advance the site and study deliverables.

**You are**:

- BS/BSc/MS/MSc or equivalent + 4 years of clinical research experience
- Skills in more than one language are an advantage in this role. English is essential

**Prior Experience**
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
- Site Management/Monitoring (CRA) experience (preferred)
- Project management experience preferred in the clinical development area
- Ability to lead, troubleshoot and influence for delivery
- Independent approach

**Technical Competencies**
- Demonstrated knowledge of clinical research processes and global and local regulatory requirements; ability to gain command of process details
- Demonstrated ability to work in cross-functional matrix environment
- Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

**Why ICON?**

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


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