This is how you will make the difference
Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements. Develops and maintains liaison with clinical investigators, clinical research organisations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval. Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports. May assist with design, development, and monitoring of clinical evaluation projects.
Trains investigators and site personnel. Includes headquarter and field clinical research associates (CRA). Implements and prepares the clinical development strategy as outlined by the clinical teams. May contact and recommend qualified investigators to perform studies and initiate clinical trials. Ensures recruitment and retention of patients.
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialised knowledge and skills normally acquired through higher education.
What you bring
In addition this position requires:
- Minimum 3 years of experience in a CRA or similar role in the Medical Devices or Pharma
- Relevant education
- Ability to work independently
- Excellent communication skills
- Fluent in Swedish and English
- Knowledge in IT systems
- Norwegian and Danish language skills