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
Munich
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.

Office based – Munich

Qualifications

  • Bachelor or higher degree in life sciences, nursing or medical technology
  • 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 60%) including overnight stays where necessary
  • Fluent in German and 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

 

Fixed term contract

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
  • Scientifical Degree
  • At least 1 year experience in Clinical Studies management
  • Good knowledge of English language
  • Good interpersonal relationships
  • DM 15.11.2011 requirements
  • Master in Clinical Research discipline preferred
Apply

Head of Biostatistics


Location
Desio, Italy
Job Description

Department: Biometrics

Job Type: Permanent, Full-time

We are looking for a suitable candidate to head our Biostatistics Unit and lead a team of biostatisticians. Main responsibilities:

  • Plan, coordinate and supervise the activities of the Biostatistics group to ensure timely project deliverables
  • Ensure scientific and quality requirements are met
  • Ensure processes are correctly applied within the Biostatistics group
  • Define the timeframes and costs of each project, collaborate with other staff members in preparing the biddings and invoices for the Sponsors
  • Establish and maintain SOPs related to Biostatistics
  • Establish and maintain document/programming standards
  • Contribute to hiring and on-boarding of new associates and act as a mentor for junior staff

 

Job Requirements:

  • Master Degree in Statistics (or equivalent degree) with 10 years of experience
  • Fluency in English (oral and written)
  • Strong planning and organizational skills
  • Very good communication and presentation skills
  • Quality and detail oriented with high standards
  • Good leadership skills. Ability to give effective guidance to Biostatisticians
Apply

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