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Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.
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About the role
- As a Site Engagement Liaison(Johannesburg South Africa), you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
- You will be a part of ICON Strategic Solutions, embedded to a sponsor.
- The Site Engagement Liaison is the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies.
Responsible for relationship building and management:
- Usher investigator sites through site activation and study activities from study start up to close out.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Lead effective site recruitment planning and implementation of plans at the country and site-level, consistent with global plan and local targets.
Responsible for proactively providing local intelligence:
- Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
- Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
- Understand targeted site criteria as well as services delivered to target sites. Track that all such services are provided consistently and in a timely manner.
Accountable for study start-up, activation, and execution to plan for targeted sites:
- Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating client functions to standardize processes and deliver activation in line with the targeted site strategy.
- Confirm (and educate where needed) that sites are familiar with client requirements for study start up and facilitate the availability of MSAs when feasible.
- Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
- Conduct SIVs if required
Responsible for process, standards, and oversight:
- 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.
Accountable for study start-up, activation, and execution to plan for targeted sites:
- Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating client functions to standardize processes and deliver activation in line with the targeted site strategy.
- Confirm (and educate where needed) that sites are familiar with client requirements for study start up and facilitate the availability of MSAs when feasible.
- Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
- Conduct SIVs if required
Responsible for process, standards, and oversight:
-
- 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.
Qualifications
A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of Education/Experience:
- BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience.
- Skills in more than one language are an advantage in this role. English is required
- 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
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