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 SAS Programmer


Location
Desio, MB
Job Description

Department: Biometrics Deparment

 

Job Type: Permanent, Full-time

 

Principali responsabilità:

 

  • Sviluppare programmi SAS per la generazione di dataset, tabelle e strumenti in accordo con le guideline ICH E3; programmi, macro e utilities per il data cleaning
  • Generare dataset SDTM/ADaM in accordo con gli standard CDISC
  • Preparare i documenti necessari alla validazione di programmi e macro sviluppati
  • Effettuare Quality Check
  • Collaborare con la funzione di Data Managment per implementare controlli in accordo con il Data Validation Plan
  • Verificare i requisiti per gestire dati clinici esterni e sviluppare programmi SAS per importare o riconciliare dati clinici esterni
  • Sviluppare e validare programmi SAS per identificare Protocol Deviations
  • Preparare, mantenere ed archiviare la documentazione relativa alla programmazione SAS

 

Profilo ideale:

 

  • 3 anni di esperienza nel ruolo o in ruolo analogo, in contesto farmaceutico o CRO
  • Preferibile laurea in Biostatistica o Statistica
  • Ottima conoscenza della lingua inglese
  • Sarà considerato requisito preferenziale l’esperienza pregressa nell’ambito della Biostatistica
Apply

Research Methodology Associate


Location
Desio
Job Description

Research Methodology Associate

 

Department: Medical Affairs

 

Job Type: Full-time, Fixed-Term contract

 

The Research Methodology Associate, under the supervision of the Head of Medical Affairs, is in charge of the following activities:

  • identify and evaluate innovative, more efficient statistical methods for ready-to-use application in trials and projects
  • deliver innovative statistical solutions in an applied environment related to clinical trial design
  • cover statistical methodology for experimental design and analysis of clinical trials
  • provide consultancy to, and collaborate with, fellow statisticians and medical scientists and other key roles across clinical research
  • undertake scientific literature review and critical reading
  • review the study objectives and endpoints with the Sponsor’s representative, as applicable
  • lead and participate in more strategic activities such as developing projects in different statistical areas that deliver broad improvements to the way clinical trials are designed and analyzed
  • develop and implement new methodology and interact with external scientists and regulators through publications, presentations and cross-industry collaborations
  • provide ‘just in time’ consulting and mentoring primarily for clinical trial design questions
  • proactively identify new areas where statistical innovation can add value
  • develop collaborative relationships with the scientific/academic community
  • use statistical expertise to influence the design of key clinical trials that are instrumental both to Sponsor, patients and the wider scientific community
  • urge applying scientific competence on practical problems, for the benefit of patients
  • be able to design data acquisition trials, assess results, analyze trends, act in a consultancy capacity, use statistics to make forecasts and to provide projected figures, present information in a variety of formats, convey complex information to people who may not be specialists, liaise with colleagues, attend meetings
  • work regularly in a global, cross-skilled setting with manager, colleagues and customers
  • be aware of statistical issues related to the evolving scientific, regulatory and Sponsor landscape
  • act as specialist in applied statistical methodology to foster methodological innovation in clinical statistics

 

Requirements

  • Degree in statistics or scientific fields with a specialization in medical or epidemiological statistics
  • Knowledge of statistics and its applications to clinical trials
  • Knowledge of drug development process and HA guidelines
  • Knowledge of SAS system
  • Good knowledge of english
Apply

Accounts Receivable Associate


Location
Desio
Job Description

Accounts Receivable Associate

 

Department: Administration

 

Job Type: Full-time

 

Principali responsabilità:

 

  • Gestione costi relativi alla sperimentazione
  • Interfaccia diretta con i centri di sperimentazione e con gli sponsor
  • Gestione consuntivi dei fornitori esterni legati alle attività relative agli studi clinici
  • Creazione e gestione degli ordini di acquisto
  • Invio e gestione delle richieste di emissione fatture ai centri di sperimentazione
  • Verifica della corretta associazione delle fatture in entrata (GR/IR – good receipt/invoice receipt)
  • Predisposizione e aggiornamento del budget degli studi
  • Gestione dei pagamenti

 

Requisiti

  • Laurea in Economia o equivalenti
  • Buona conoscenza di Excel (tabelle pivot)
  • La conoscenza di SAP sarà requisito preferenziale
  • Conoscenza della lingua inglese
Apply

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

Statistician


Location
Desio (MB), Italy
Job Description

The Statistician, under the supervision of the Head of Biostatistics, is in charge of the following activities:

  • Be responsible for all statistical tasks on the assigned clinical trials, e.g. clinical trial design, sample size estimation, analysis plan, analysis populations, reporting activities, exploratory analyses
  • Review the study objectives and endpoints with the Sponsor’s representative
  • Generate the randomization list and collaborate with the Data Manager to produce the corresponding validation documents, and perform the acceptance tests
  • Collaborate with the Data Management team in finalizing and developing the eCRF
  • Write a detailed statistical analysis plan
  • Develop programs or collaborate with the SAS programmer to generate analysis datasets/tables/figures/listings for clinical trials and/publications
  • Write the Statistical Report and/or the statistical sections of the ICH Clinical Study Report

 

Requirements:

  • Master’s Degree in Statistics (or equivalent degree)
  • 2 year of experience
  • Good knowledge of English
  • Strong planning and organizational skills
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

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