Senior Central Monitor
- Experience Level
- Experienced (non-manager)
Senior Central Monitor
Location: UK / South Africa Home or Office Based
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Working as a Senior Central Monitor outsourced to a single pharmaceutical company you will be providing services which include working within the Risk Management-Central Monitoring Group and leads clinical study teams in the study-specific design and implementation of Analytical Risk-Based Monitoring (ARBM) on clinical trials (Ph I-IV).
The Senior Central Monitor is responsible for a range of tasks that spans the areas of risk identification & mitigation, data analysis, leading cross-functional teams, communicating with study team members on multiple levels, providing ongoing training on ARBM-related processes to teams, and participating in departmental initiatives related to innovation and process
- Services rendered will adhere to dedicated sponsor SOPs, WIs, policies, local regulatory
• Lead central study teams (including trial managers, data managers, study physicians, study scientists,
quality colleagues, and statisticians) in the identification of critical study data/processes and in
related potential risks.
• Coordinate trial team translation of identified risks and critical data/processes into risk mitigation
and oversight plans to be followed during study execution.
• Lead the central study team in making appropriate decisions regarding site management,
data review, and contingency plans and provide their own input into related study plans.
• Coordinate with the cross-functional central study team to ensure compliance with the risk oversight
plan established during ARBM design and to oversee site risk parameters.
• Responsible for ongoing study and operational data reviews, as well as associated follow-up to
resolution of their findings in conjunction with appropriate central and field team members. This is
to be accomplished through the utilization of multiple internal systems, internal/external databases,
custom report creation, and the use of a selection of data analysis and visualization tools, followed
by the proper interpretation and investigation of risk indicators and trends.
• Successfully lead recurring cross-functional study team meetings inn a virtual environment.
Organize, lead, document meetings, communicate effectively, and guide and influence colleagues in
new methodologies is critical.
• Ensure Inspection readiness for sites by maintaining complete, accurate and timely data and essential
documents in systems utilized for trial management (e.g. CTMS and eTMF) according to expectations
(metrics) and archiving retention requirements, including storage in a secure area.
• Complying with relevant training requirements and developing therapeutic knowledge sufficient for
role and responsibilities to ensure inspection readiness.
• Full utilization by timely and accurate time reporting.
- Minimum 4 years clinical trial support or pharmaceutical industry experience
- Read, write, and speak fluent English; fluent in host country language
- Knowledge of ICH-GCP and local regulatory requirements
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse)
- Prior experience using Clinical Data Management Systems
- Basic knowledge of medical terminology
- On site monitoring experience preferred
As a Senior Central Monitor you won’t be required to travel so this position could suit a CRA who no longer wishes to travel. Or a Clincal Data Coordinator / Data Manager looking for a change in direction. You can be home or office-based so this flexibility could enhance your work/life balance.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.