At OPIS, we are always looking for qualified candidates to join our team. With offices throughout the EU,
we offer a wide range of exciting career opportunities in a variety of regions. We further the professional development of all our employees through continuous qualification and training programmes that encourage personal
and professional fulfillment. Begin your journey with OPIS today by browsing through our latest job opportunities or follow us on LinkedIn. If you are interested in joining OPIS, please send your CV to jobs@opis.it.

FEATURED JOB OPPORTUNITIES
At OPIS, you will find open positions in various areas:

Senior Clinical Research Associate


Location
Desio (MB), Italy
Job Description

We are looking for an experienced CRA with expertise in performing on-site pre-study, initiation, monitoring and close-out visits according to ICH/GCP, regulatory and protocol specific requirements.

Qualifications

  • Masters Degree in scientific/healthcare related subject
  • At least 2 years monitoring experience of clinical studies Phase I – IV/observational studies
  • ICH/GCP knowledge, basic understanding of regulatory affairs
  • Full understanding of Serious Adverse Event (SAE) reporting and follow-up of SAEs
  • Good planning, organization and problem solving abilities
  • Good communicative and interpersonal skills
  • Willingness for travel (up to 50%) including overnight stays where necessary
  • Good knowledge of English
  • Valid drivers license
Apply

Clinical Research Associate


Location
Desio (MB), Italy
Job Description

We offer the opportunity to start a career in the clinical research of drugs and medical devices. An entry level positions as Clinical Research Associate/Clinical Monitor for those with a scientific background, willing to travel in Italy, interested in the research field.

We will consider profile with at least one of the following experiences:

  • Postgraduate Masters Degree in Clinical Research related topic
  • At least 4 months of professional experience in the field of Clinical Research (Pharmacovigilance, Submission, Study Coordinator, Data Management)

 

Qualifications

  • Masters Degree in scientific/healthcare related subject
  • ICH/GCP knowledge, basic understanding of regulatory affairs
  • Good planning, organization and problem-solving abilities
  • Good communication and interpersonal skills
  • Willingness to travel including overnight stays where necessary
  • Good knowledge of English
Apply

Senior Data Manager


Location
Desio (MB), Italy
Job Description

Department: Biometrics

Job Type: Permanent, Full-time

We are looking for a Senior Data Manager, able to work independently on all data management tasks related to the assigned clinical trials. The main responsibilities include:

  • Design the paper or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, Project Manager, Statistician and ICT staff
  • Prepare/review the data management documents (e.g. Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Protocol Deviation Handling Document, etc.)
  • Prepare and validate the eCRF/clinical databases and related tools
  • Organize/perform trainings for project team
  • Coordinate/perform data cleaning activities
  • Perform coding activities of medications and medical terms using medical dictionaries
  • Perform SAE reconciliation when required
  • Define the requirements to handle external clinical data and prepare the Data Specifications Document, and perform import and reconciliation of external clinical data
  • Perform database lock
  • Perform quality control according to the Data Management Plan
  • Liaise with Sponsor and third parties regarding data management activities
  • Track activities and milestones to ensure timely project deliverables
  • Contribute to on-boarding of new associates and act as a mentor for junior staff

Requirements

  • Master’s Degree in Statistics (or equivalent degree)
  • 5 years of experience as Data Manager in CROs or Pharmaceutical companies (mandatory)
  • Solid knowledge on relational databases and programming languages (SQL)
  • Knowledge of SAS system (Base, ODS)
  • Experience in developing CDISC standard specifications
  • Solid knowledge of HA requirements that pertain to pharmaceutical research and specifically to Data Management
  • Good knowledge of English
  • Good communication skills and team work
  • Strong planning and organizational skills
Apply

GCP Auditor


Location
Desio, Italy
Job Description

Department: Quality Management

Job Type: Permanent, Full-time

Scopo della posizione sarà esecuzione di audit GCP on site, audit di qualifica fornitori e audit di sistema e gestione del sistema qualità aziendale rispondendo direttamente all’Head of Quality Management.

 

Principali responsabilità:

  • Preparazione e conduzione di audit GCP on site, audit di sistema e di qualifica fornitori
  • Collaborazione con il team di Quality Management nella gestione del Sistema Qualità dell’azienda
  • Verifica e aggiornamento delle procedure interne in collaborazione con il team di Quality Management
  • Gestione non conformità e CAPA in collaborazione con il team di Quality Management
  • Coinvolgimento nella preparazione ed esecuzione di training aziendali nelle aree di competenza
  • Collaborazione nella formazione delle risorse junior del team
  • Punto di riferimento per la gestione di problematiche relative alle GCP

 

Profilo ideale:

  • 3/4 anni di esperienza nel ruolo o in ruolo analogo, in contesto farmaceutico o CRO
  • Laurea in discipline sanitarie/scientifiche
  • In possesso dei requisiti necessari per l’attività di auditing sulle sperimentazioni o sui centri sperimentali (DM 15/11/2011 art. 5)
  • Ottima conoscenza della lingua inglese
Apply

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