Central Monitor II

1 month ago

Canberra, Australia Pharmiweb Full time
Description

Central Monitor ( Remote Monitor/Risk-Based Monitor) - Romania

Sponsor Dedicated

The purpose of the Remote Monitor is to de-risk studies as early as possible by analyzing data at the macro-level for insights that are not visible when monitoring individual data points /study sites-thereby enabling the Sponsor to take early interventions to mitigate potential risks to the patient, the investigator, the data, the study, and the Sponsor business.

Job responsibilities

  • Inspect near-real-time aggregate clinical and operational data from multiple sources (eCRF, vendor data, digital health/wearables, etc.). Utilize data analytics and visualizations to uncover insights and see complex patterns within data.
  • Use Key Risk Indicators (KRIs) to identify significant issues and emerging risks at the study site, program, country.
  • Clearly document the detected issue / emerging risk.
  • Translate the issue / emerging risk-the situation, the significance / implication of the data insight, and what further action is required-breaking down complex concepts into simple language.
  • Communicate findings as per planned process to ensure that all cross-functional stakeholders have the same understanding of the issue / emerging risk so that the appropriate follow-up action can be taken.
  • Arm the primary site monitor with important information that will enable Sponsor to be the clinical partner of choice; allowing monitors to work differently with site staff and have more productive discussions with our Investigator partners.
  • Work collaboratively in the pursuit of quality with the primary site monitor, the Study Team and cross-functional departments.

Qualifications
  • Bachelors degree in related field, may include life sciences, risk-based discipline;
  • Minimum of 2 years of clinically related or data trend analysis experience, 1 year is preferable in clinical research monitoring.
  • Experience working in an RBQM-model or similar experience with risk-based environment preferred.
  • Demonstrated current in-depth knowledge and understanding/or willingness to learn of appropriate therapeutic indications, regulations, and ICH/GCP guidelines as they relate to the conduct of clinical trials (study management, data management and regulatory operations). TA experience preferred in one of the following areas (Neuroscience, Oncology, Immunology, Eye Care, Medical Aesthetics, Women’s Healthcare, GI).

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

#LI-KU1

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