Romania Job Openings
Syneos - Clinical and Corporate - Prod
Central Monitor II - Homebased in Romania
Bucharest
FULL TIME
August 19, 2024
Central Monitor II
Homebased in Romania
Single Sponsor (FSP)
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Job responsibilities
- Inspect near-real-time aggregate clinical and operational data from multiple sources (e CRF, 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.
- 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).
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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