Central Monitor

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