Senior Clinical Data Manager

Medical · Oslo, Oslo
Department Medical
Employment Type Full-Time

Are you a tech savvy Clinical Data Manager looking for opportunities in a dynamic, fast-growing and innovative company? If yes, then come join our Vaccibody team!


Vaccibody continues to grow, and we are now in search of a Senior Clinical Data Manager. You will be our in-house expert on Data Management activities across all development projects in Vaccibody. Moreover, you will be overall accountable for oversight and implementation of end-to-end data management processes in clinical trials from early planning to final reporting. 

 

About the role

 
The Senior Clinical Data Manager is overall responsible for cross-functional coordination and alignment of the data management related processes in clinical trials, ensuring high quality data management deliverables. You will oversee and analyze data management related metric reports and data output in clinical trials and be a key member of cross-functional teams. The candidate is expected to proactively engage in team discussions bringing the data management expertise into play and contribute to fostering an environment of collaboration. You will work both independently and be part of a multi-disciplinary team and will participate in cross-functional improvement projects focusing on data handling, data sharing, validation and reporting as well as being a main driver in process optimization initiatives. 


Key responsibilities

  • Responsible for end-to-end data management processes in clinical trials 
  • Provide input to and review of CRO proposals for new trials 
  • Be involved in the development of clinical trial synopsis and protocols 
  • Recognize and resolve protocol issues that may impact database design, data validation and/or analysis and reporting  
  • Contribute to development of eCRF 
  • Review and contribute to Data Handling Plan, Data Review Plan as well as performing User Acceptance Testing and system validation as applicable  
  • Serve as subject matter expert on all aspects of data management and data standards that include industry standards (CDISC), regulations and processes 
  • Ensure robust process for data cleaning and query handling  
  • Understand third party data requirements and reviewing these 
  • Ensure adherence to GCP, DM standards, SOPs and external guidelines 

 

Who are we looking for?

When hiring new employees, we look for the individuals who we think would be a good fit with our collaborative and inclusive company culture. You enjoy working together with other people in cross-functional team structures. Moreover, you appreciate working in an international environment.


To succeed and thrive in this role we believe that you bring an innovative, analytical and flexible mindset. You are able to handle several projects at once and enjoy working in various cross-functional team structures. Your eye for details, tech savviness and strong analytical skills helps you excel in your field. On a personal level, we believe that you appreciate and actively engage in strategic discussions just as easily as in keeping track on the practical activities. You work in a structured manner and come across as efficient in your way of communicating.

 

Your qualifications

  • University degree in life science, computer science or equivalent 
  • Minimum 5 years of industry experience within drug development / clinical data management  
  • Profound knowledge of GCP/GDP and DM standards  

  • Knowledge of early phase clinical trial planning, setup and execution within oncology and/or infectious disease is preferred 
  • Demonstrated experience with various EDC applications (i.e. Veeva Vault, RAVE, Oracle RDC, others) 
  • Proficient knowledge of and experience from working with clinical databases, CDISC standards (SDTM and CDASH as DB standard) and SAS 

  • Extensive experience with CRO oversight activities focused on data management 
  • English fluency, both written and spoken

 

Location for this position is not fixed, however preferably you are located in Norway or Denmark. The position reports to Head of Development Operations.

 

Applications will be reviewed on a rolling basis. We look forward to receiving your application! We do not accept applications by mail. Should you have any further questions regarding the position, please reach out to us: recruitment@vaccibody.com

 

Why join our Vaccibody Team?


At Vaccibody, we offer a fun and dynamic international working environment. The people are at the heart of our organization, which is why we always keep striving to offer a workplace where we cheer each other on and find motivation. Your skills and competencies are unique and to ensure continued development our aspiration is to provide you with good opportunities for personal growth. We care about each other.

About us


Vaccibody is a clinical-stage biopharmaceutical company, founded in 2007. Since then, we have become one of the world’s most exciting Biotech companies, rapidly growing. Today we are counting more than 60 amazing employees with medical and development teams, manufacturing, bioinformatics, and research teams. We are dedicated to the discovery and development of novel immunotherapies, and are using the Vaccibody technology to generate therapeutics with best-in-class potential to treat cancers with a high unmet medical need. Furthermore, we also focus our research on infectious diseases and immune tolerance. We closely collaborate with Roche and Nektar Therapeutics. And we are proud to have entered into a worldwide license and collaboration agreement with Genentech, a member of the Roche Group, to develop individualized neoantigen cancer vaccines.

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  • Location
    Oslo, Oslo
  • Department
    Medical
  • Employment Type
    Full-Time