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regulatory affairs manager jobber i Oslo

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Job Post Details

Calluna Pharma AS is seeking an experienced Clinical Trial Coordinator / Manager - job post

Calluna Pharma
4.8 out of 5
Oslo
Fast
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Jobbtype

  • Fast

Sted

Oslo

Full stillingsbeskrivelse

We are looking to strengthen our team with a Clinical Trial Coordinator / Manager with passion for clinical development and extensive experience in clinical trial operations.

As a Clinical Trial Coordinator / Manager, you will be part of our clinical operation team and take part in day-to-day work to support a wide range of activities within clinical development.


Job responsibilities

  • Review or prepare study documents such as study specific plans, manuals, eCRF/guidelines, ICF, trial protocol
  • Participate in vendor selection and management
  • Plan and manage trial oversight activities by developing or maintaining appropriate trackers
  • Contribute to risk management activities
  • Oversee monitoring activities performed by CRO, review monitoring reports, participate in co-monitoring visits
  • Oversight and coordination of kit supply and sample shipment to central labs
  • Oversight and QC of study documentation (TMF)
  • Support to clinical database setup, testing and management
  • Support IMP handling and tracking
  • Contribute to implementation and maintenance of clinical Quality Management System
  • Provide support in handling of change controls, protocol deviations, and CAPAs
  • Support clinical trial applications to regulatory authorities and ethics committees as needed
  • Work closely with cross functional teams (e.g., with pre-clinical/translational, regulatory affairs, clinical pharmacology, quality)


To be considered for this role you will meet the following criteria:

  • More than five (5) years of experience as a clinical study coordinator/ clinical research associate or clinical trial manager preferably from Biotech, or CRO or Pharmaceutical companies
  • In-depth knowledge of ICH-GCP and other relevant regulations and guidelines
  • Excellent verbal and written communication skills in English
  • Excellent experience in Microsoft Office suite of applications
  • Experience with eTMF and Electronic Data Capture (EDC)
  • Ability to work with multiple projects and tasks in parallel


Location and reporting line

The position is full-time and offer a flexible working arrangement. Flexibility with regards to working hours and travel is required. The position is currently reporting to the SVP Clinical Operation and PV.


Remuneration

Calluna Pharma offers a challenging and exciting role in one of Norway’s most innovative pharmaceutical companies. The company offers a competitive remuneration package including base salary and share options.


Please send your application to renate.birkeli@callunapharma.com as soon as possible.


Contact persons for details about the position:

SVP Clinical Operation and PV Margrethe Sørgaard, T: +47 970 19169

VP Clinical Research Sylvia Vetrhus, T: + 47 922 01 571

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