SITE SUPPORT SPECIALIST (SSS), Observational Studies– Modena (Italy)
MediNeos, an IQVIA company, is a leader brand in Observational Research for the Life Sciences, with a specific focus on international,multicenter, observational studies, patients’ registries and Real World Data projects.
As full Member of the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCEPP), our teams conduct Post Authorization Safety Studies (PASS) and Drug Utilization Studies (DUS) and epidemiological study designs (Cohort and Case Control studies, Cross Sectional studies, Case Series, etc.)
Working as a SSS within Medineos Clinical Operations team, you will be responsible for:
- supporting sites/investigators during data collection activities to ensure the achievement of the target population agreed with Sponsor with respect of the MediNeos quality standard and planned timelines
- supporting clients and senior member of the team in risk assessment definition in the starting conduct phase of the study and during the stucy conduct. The setting will be the one of international studies where you’ll have the chance to collaborate with International clients and sites.
While projects vary, your typical responsibilities might include:
- Upon indication of Study Manager or Clinical Operation Manager, to monitor the patient enrolment and data cleaning
- To conduct activities by directly contacting Investigational Sites and identifies the causes of delays or criticalities linked to the enrolment/observation of subjects or to the queries’ resolution
- Phone HelpDesk dedicated to Clinical Investigators in order to solve methodological and scientific issues raised up by Clinical Monitor/CRA during monitoring/enrolment/cleaning phase
- To Elaborate the operative calendar of monitoring activities
- To train the Clinical Monitors and the Lead Clinical Monitors involved in any study in order to ensure the proper usage of the data collection tools and for the proper resolution of the queries
- To complete scientific, administrative and technical documentation of the study; obtain local ethical and administrative authorizations
- To create and maintain the archive of the study (TMF, ISF etc…) and database recording all the associated documentation
- To manage feasibility activities for initial selection of Site, executing monitoring activities both remotely and on-site
- To support Site Staff with query resolution and maintaining with them contacts and updates
- To collect, analyze and summarize data documenting the progress of the study interacting with internal and external stakeholders (sponsors, investigators and monitors ‘team)
Desired Skills and Experience
- 1-year experience as CRA or Data Manager in the field of clinical trial
- MSc degree with strong record of academic achievement, preferably in LifeScience field; 2nd level Master in clinical research topics will be considered a plus
- Excellent Microsoft Office Skills
- Solid communication skills
- Proficiency both in English and Italian
- Knowledge of German or Spanish language will be considered a plus
- Ability to be multi-tasking in a fast-paced environment and to work on a team
Location: office based (Modena)
Permanent contract since beginning.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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