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The Central Monitor (CM) will perform centralized and prompt monitoring activities for Phase I-IV clinical research and/or non-interventional studies (NIS) in accordance with project plans, the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements as well as ensure patient safety and data integrity using a variety of statistical and analytical tools. The CM will analyze site and study level data in the applicable data analytics tool(s) and may identify risks and trends at the site and study level, as well as operational performance issues. The CM shall summarize the analysis, provide recommendations, and share with the project team as appropriate for operational considerations/actions. The CM performs all tasks routinely and independently with minimal oversight per Alimentiv policies, SOPs, Work Instructions, and guidance documents, and in line with the study monitoring plans. May provide support to other CMs including training and mentoring.
Project Support
- Reviews and understands protocol(s), critical data process, safety and data integrity risks related to protocol execution.
- Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.
- Assesses factors that may affect patient safety and clinical data integrity at an investigative site such as protocol deviations and pharmacovigilance issues.
- Assesses site data quality, risks, trends as well as operational performance and summarizes the findings for CRA review.
- Utilizes a KRI dashboard, metrics, reporting systems and other analytical tools to synthesize data trends, issues, action items for CRAs and other functional roles for follow-up.
- Escalates serious issues to project teams and develops action plans with guidance.
- Contribute to the development of the study specific analytics strategy, work to develop advanced analytics.
- Documents observations noted during reviews and writes queries, protocol deviations and/or action items as needed for action by sites, CRAs or other functional team members.
- Perform prompt monitoring activities, remote data review at pre-defined time windows following data entry in the eCRF.
- Documents completion of activities via tracking, reporting and/or other requirements per project plans (e.g., Monitoring Plan).
- For assigned activities, understands the project scope, budgeted hours and timelines; manages patient and site level activities assigned to the Central Monitor per project plans to ensure project deliverables, objectives and timelines are met.
- Must be able to adapt quickly with some oversight from the project team (e.g., Project Manager, Clinical Operations Lead or Team Lead, Central Monitoring), to changing priorities to achieve goals/targets.
- Prepares for and attends Investigator Meetings and/or Sponsor meetings.
- Participates in project team meetings, training sessions according to project specific requirements.
Department Support
- Contribute to the continuous improvement of central monitoring and the wider organization through information sharing, training and education.
- Coach, mentor and/or train peers.
- May participate in and/or lead the development, review and implementation of processes, policies, SOPs, Work Instructions and associated documents related to central monitoring.
- May participate in departmental and/or cross-departmental initiatives.
Qualifications
- The successful candidate will possess a minimum of a bachelor's degree and 1-3 years of relevant experience in Monitoring & Site Management or Clinical Data Management with knowledge and prior experience of Risk Based Monitoring concepts and Good Clinical Practice/ICH E6 (R2).
- Must demonstrate proficiency with MS Office, with a mastery of MS Excel, understanding of data analytics tools and understanding of statistical analysis techniques, visualizations and tools.
- The ideal candidate should demonstrate the following attributes: strong analytical skills, excellent verbal and written communication skills, as well as strong presentation skills with the ability to inform, influence, convince and persuade
- The candidate should also have strong time management, technical and organizational skills, strong problem-solving skills and ability to work both cross-functionally and independently in a global environment.
WORKING CONDITIONS:
- Home-based
*Accommodations for job applicants with disabilities are available upon request
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