Centralized Monitor (Romanian Speaker)- Sponsor Dedicated (Home-Based) Bucharest

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

data, the study, and the sponsor business. The Central Monitor is sponsor’s first responder in identifying, triaging, and escalating
- level risks.

Inspect
-
- 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
- functional stakeholders have the same understanding of the issue /emerging risk so that the appropriate
- 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
- functional departments. Participate in Health of Study Meetings.

Contribute to the ongoing development / advancement / improvement of the systems—providing requirements that will further enable data analysis (i. e. what to look for, how to best present the data so that you can see what you’re looking forward) and testing the system at the study level to ensure system quality. Be a project champion across , supporting the execution of the processes as part of
- functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).

Bachelor’s degree in related field, may include life sciences,
- based discipline. Minimum of 3 years of clinically related or data trend analysis experience, 1 year is preferable in clinical research monitoring. Experience working with
- based clinical environment preferred.

Demonstrated current
- 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).

Comfortable with use/operation of data analytics and visualization tools on a daily basis in support of core responsibilities.

Embraces the role of “first responder” in the pursuit of quality through data analytics.

Ability to evaluate large volumes of data from multiple sources and complex issues from multiple perspectives, to identify and investigate atypical patterns/trends, to conduct root cause analysis, and to effectively raise issues to sponsors stakeholders for appropriate corrective action.

Embraces a curios mind set whilst evaluating data or conducting root cause analysis, asking questions of the data in front of them, not fulfilling preconceptions.

Ability to use critical thinking, functional expertise, and good judgement in support of objective, pragmatic SMART SURE decision making to drive effective and timely outcomes.

Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner