Job Overview:
The Central Monitoring Specialist is responsible for the execution of key Central monitoring (Site, subject and study level review as applicable) activities and in assisting the execution of several key activities. The Central Monitoring Specialist collaborates with the study team to execute Central Monitoring and comply with the applicable plans for the study. Central Monitoring Specialist conducts review of the applicable Informatics platform and communicates findings at the country, study, site, subject level. Is responsible for the conduct of central monitoring activities in a timely manner and reporting, recommending changes in risk profile, and escalation as appropriate. May conduct risk assessments, review risk indicators, recommend mitigations to project teams. Deep dive into identifying site and subject level risk in non-contributing RI which may overall affect the study level risk.
Summary of Responsibilities:
- Performs the Central monitoring activities for more than 3 studies and multiple customer portfolios and ensure accurate tracking and status reporting of studies in their remit.
- Support the leads in preparation of detailed study risk assessment.
- Act as back up for the leads in the Central Monitoring activities.
- Create, review and compare monthly status reports of study specific important risk indicators from data sources.
- Organize Study Risk Assessment meetings.
- Take minutes or fill out the Study Risk Assessment tools.
- Support the leads in preparation of detailed study risk assessment and may coordinate Site Risk Assessment activities.
- Follows up with the outstanding site findings, query resolution and administrative issues.
- Support in populating the required tools with the baseline site risk profile.
- Supports the development of informatics Platform requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
- Write scripts for User Acceptance Testing and perform UAT for study specific and new platforms and tools.
- Draft the Configuration Plan and all other applicable Plans in collaboration with the study team and update these on an ongoing basis including the refinement of visualizations and any edits in line with emerging risk profile and study changes.
- Edits the Central Monitoring and other applicable plans in line with emerging risk profile and study changes.
- Populates the tools, tests variable risk factors, adjusts trigger levels, study specific risk factors and central monitoring parameters.
- Performs ongoing reviews, prepares and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution.
- Proposes potential changes to monitoring intervention level to the team.
- Prepare and distribute the quality risk reports at intervals during study conduct and at study close out.
- Upload the monthly risk review reports in the e-TMF or Veeva vault or central repository as necessary.
- Prepares and distributes the Project/Study Reports at intervals during study conduct and at study close out.
- Perform subject level review activities and coordinate with the stakeholders to address the findings if applicable.
- Performs study analytics reviews as per the applicable plans and communicate the findings appropriately.
- Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
- Prepares and distributes the Project Quality and Risk Reports at intervals during study conduct and at study close out.
- Identify the need for study scope changes and risk profile changes.
- Evaluates and collates process improvement suggestions and submits to leadership.
- Evaluates and submits ideas and justification for improved systems and tools to leadership.
- Submits ideas to increase sales by positioning central monitoring and Informatics Platform with clients.
- And all other duties as needed or assigned.
Qualifications (Minimum Required):
- University / college degree (life science preferred) from an appropriately accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Good ability to work with peers.
- Good analytical skills, strong detail focus and accuracy.
- Good planning, time management and organizational skills.
- Some influencing, negotiation and problem solving skills.
- Some project and risk management skills.
Experience (Minimum Required):
- Minimum of 3-5 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g., project management, clinical monitoring, data management and informatics.
Preferred Qualifications Include:
- Post-graduation in Life sciences or any other applicable qualification and experience.
Physical Demands/Work Environment:
- Standard office or home working equipment required.
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