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

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

Senior SAS programmer


Location
Desio (MB), Italy
Job Description

Department: Biometrics

Job Type: Permanent, Full-time

We are looking for a Senior SAS Programmer able to work independently on all SAS programming activities related to the assigned clinical trials. The main responsibilities include:

  • Develop SAS programs for generating datasets, tables, figures and listings for clinical trials (according to ICH E3) and/or publication and/or Health Authorities requests
  • Generate CDISC compliant datasets (SDTM/ADaM) and related documentation
  • Develop standard SAS macros and prepare the corresponding validation documents
  • Develop SAS programs/macros and utilities for data management
  • Establish and implement programming rules
  • Collaborate in establishing and maintaining SOPs related to SAS programming
  • Collaborate in establishing and maintaining document/programming standards.

Job Requirements

  • At least 3 years of experience in a Pharmaceutical company or CRO.
  • Proven knowledge of SAS
  • Proven knowledge of CDISC and experience in developing CDISC standard specifications and datasets (SDTM, ADaM)
  • Knowledge of other statistical software packages
  • Knowledge of statistics and its applications to clinical trials.
  • Analytical approach and effective problem-solving skills; ability to manage multiple activities
  • Ability to work independently
  • Strong interpersonal skills. Good team player
Apply

Head of Data Management Unit


Location
Desio (Italy)
Job Description

Department: Biometrics

Job Type: Permanent, Full-time

We are looking for a suitable candidate to head our Data Management Unit and lead a team of data managers and programmers to:

  • Plan and supervise the activities of the Data Management group in order to ensure timely and high quality deliverables
  • Ensure processes are correctly applied within the Data Management group
  • Liaise with Sponsor and third parties with regard to data management activities
  • Collaborate with the ICT Dept. on the EDC system and related tools
  • Define the timeframes and costs of each project
  • Establish and maintain SOPs related to Data Management
  • Establish and maintain document/programming standards.

Job Requirements:

  • At least Master Degree in Statistics (or equivalent degree) with 10 years of experience in clinical data management
  • Solid knowledge and experience in drug development process and HA guidelines
  • Solid knowledge on relational databases and programming languages like SQL. Knowledge of SAS system (Base, ODS)
  • Experience in developing CDISC standard specifications and datasets (SDTM, ADaM)
  • Fluency in English (oral and written)
  • Strong planning and organisational skills
  • Very good communication and presentation skills
  • Quality and detail oriented with high standards
  • Good leadership skills. Ability to give effective guidance to Data Managers and SAS Programmers.
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

Senior Medical Writer


Location
Desio, Italy
Job Description

Job Type: Permanent, Full-time // Consultant

Main responsibilities:

  • Draw up, edit and review clinical documents such as clinical study reports, statistical analysis plans, study protocols, patient information and informed consent forms and other medical/regulatory documents
  • Develop scientific manuscripts and abstracts reporting clinical study results, as well as slide and poster presentations
  • Prepare regulatory and clinical documents for drug development and registration activities
  • Take ownership of a given assignment, proactively consulting with Biometrics staff, Pharmacovigilance and Clinical Operations Units for information or guidance, as necessary
  • Coordinate and manage documents to produce submission-ready content for customers
  • Perform literature searches/reviews as necessary to obtain background information for the development of documents
  • Create/maintain audit system/trails of all document changes
  • Review the quality and accuracy of documents in English

 

Job Requirements:

  • Medical School Degree
  • Fluency in English (oral and written)
  • Strong planning and organizational skills
  • Very good communication and presentation skills
  • Quality and detail oriented with high standards
  • Familiar with Regulations, Good Clinical Practices and ICH guidelines and Company Standard Operating Procedures
Apply

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