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

at  Calluna Pharma

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