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Oncoinvent presents a unique opportunity to join an expanding pharmaceutical start-up with both R&D and production established in-house which enables both hands-on lab work as well as working with external partners.

The company has solid owners and is currently in late preclinical phase with its lead product (Radspherin®) which is produced in Nydalen.

The candidates should be looking for the energy in a start up with the ambition to make a difference. Successful candidates should be flexible, team-oriented yet able to work independently, and be analytical and results oriented.

If you would like to send us an open application, please send your application and résumé to info@oncoinvent.com

 

Vacancies

Clinical Study Manager (CSM)

Oncoinvent AS is looking to strengthen it’s team by hiring a Clinical Study Manager at its offices in Oslo, Norway. The person will be responsible for managing the First-In-Human studies with Oncoinvent’s main product Radspherin®.
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Clinical Study Manager (CSM)

Oncoinvent AS is looking to strengthen its team by hiring a Clinical Study Manager at its offices in Oslo, Norway. The position presents a unique opportunity to join an expanding biotechnology start-up that is about to initiate the first-in-human/phase I studies for the lead product candidate, Radspherin®. Radspherin® is a radiopharmaceutical targeting to treat peritoneal carcinomatosis.

The candidates should be looking for the energy and enthusiasm in a start-up company with the ambition to make a difference. Successful candidates should be flexible, team-oriented yet able to work independent, analytical and results oriented.

Responsibilities include:

  • Review and input to clinical operations related Standard Operating procedures (SOPs)
  • Review and provide input to clinical study protocols and other documents for Oncoinvent sponsored studies
  • Overall responsibility for managing day-to-day activities in phase I clinical studies
  • Day-to day oversight of study activities to ensure that these are conducted in compliance with ICH/GCP, relevant SOPs and other regulatory requirements and according to plan and budget
  • Immediate reporting/communication of deviations and other significant incidences that potentially may have budgetary consequences and impact on project timelines
  • Manage Contract Research Organization (CRO) and any other vendor utilized for the phase I studies and act as primary point of contact from sponsor’s side
  • Monitor ongoing clinical CRO performance according to Key Performance Indicators (KPIs)
  • Accountable for effective management of budgets, timelines for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality
  • Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Contribute to the development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, eCRF, CSR and other key study team deliverables.
  • Track and review study milestones, tasks and timelines
  • Review of monitoring visit reports (for Pre-Selection Visits, Site Initiation Visits, Regular Monitoring Visits and Closure Visits), ensuring the CRO meets required timelines for review and submission and ensuring quality sufficient to be inspection ready at all times.
  • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
  • Provides leadership in identifying operational risks and developing mitigation and contingency plans for the phase I studies.

Requirements:

  • Minimum 5 years of experience from clinical research, preferably within Oncology
  • Minimum 2 years of previous experience within study management
  • Master’s degree in Science, Engineering, Pharmacy or similar
  • Able to work in Oslo, Norway
  • Previous experience in managing multi-sites clinical studies
  • Knowledge of ICH GCP
  • Demonstrate experience from several areas within clinical research (eg. Data Management and/or Medical Writing) is considered a benefit
  • Experience in clinical studies with a radioactive product is considered a benefit
  • Fluent in English (Norwegian a benefit)

For more information, please contact external recruiter, Borka Consulting:

Cecilie Borka at +47 928 55 352 or André Borka at +47 908 31 871. Please send your application (both motivational letter and CV) in PDF format to cecilie@borka.no. Interviews are held consecutively, please show your interest as soon as possible!

Jan Alan Alfheim

Chief Executive Officer

alfheim@oncoinvent.com

+47 464 40 045

Jan A. Alfheim is a business executive with over thirty years’ experience bringing product ideas and technology to the chemical and pharmaceutical markets, from product concept inception through discovery and development phases to final marketing campaign and launch.

With experience in research, project management, business development & partnering, company start-ups, and product launches, Alfheim comes from Nordic Nanovector ASA where he was Chief Executive Officer from 2011 until 2014 and Chief Operating Officer from 2014 to 2016. Prior to working at Nordic Nanovector, he has held various senior roles including Chief Business Officer at Clavis Pharma, President of StemPath Inc, Director of Business Development at Neurochem Inc and Project Director at Nycomed Imaging. Mr. Alfheim holds a MSc from Concordia University and a MBA from McGill University.

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