ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Site Excellence Partner is accountable for safeguarding the quality and patient safety at the investigator site and is responsible for site and monitoring oversight. The Site Excellence Partner is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. The Site Excellence Partner is accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place.
Responsibilities
Responsible for process, standards and oversight for assigned studies:
- 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.
- Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control.
- 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.
The Site Excellence Partner may be required to support some or all of the primary responsibilities of the Site Relationship Partner, as example, proactively collaborating and providing local intelligence to country outreach surveys, targeted sites strategies, study design, and Pfizer pipeline opportunities. The Site Excellence Partner may be required to support additional primary responsibilities of the Site Relationship Partner in study start up, activation, and execution to the plan for targeted sites, helping coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Pfizer communications and enhancing overall visibility into and confidence of quality of site-level activities.
What do you need to have?
Education: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
Skills:
- Read, write and speak fluent English; fluent in host country language required.
- 2+ years of clinical monitoring experience required
- Knowledge of ICH and local regulatory authority regulations regarding drug
- Clinical research experience
- Knowledge of ICH and local regulatory authority regulations regarding drug
- An advanced degree (e.g., M.S., M.B.A., PharmD, etc)
- Experience in monitoring all trial components (PSSV to COV)
- Experience in coaching/mentoring other CRAs
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
Experience preferred:
Qualifications
Training and Education
- 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 + 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
Behavioral Competencies
- Considers stakeholders including regulatory agencies and marketing when developing strategies and future directions
- Challenges people to surpass themselves in reaching their objectives using innovative solutions
- Utilizes and encourages innovative approaches to build and maintain a competitive advantage
- Acts as a champion of change across the area/region/countries; uses facts, logic and personal credibility to influence the successful implementation of process improvements
- Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration
- Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
- Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures
- Motivates through example, commitment, loyalty and enthusiasm
Non-Standard Work Schedule, Travel or Environment Requirements
- Availability to travel regularly within country and region is required.
Organizational Relationships
- Reports to Director, Clinical Site Operations
- Indirect relationship with Signal Interpretation Leads; Process, Standards & Signal Interpretation Group Lead; Site Relationship Partner; and Study Manager
Benefits of Working in ICON:
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.
At 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.
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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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