Job expirat
-Developing and growing the local business area
-Leading the Study Team and ensuring that each
member will perform their task during the study process
according to agreed timelines
- Managing project budgets
- Setting up and documenting the study outline
- Writing and preparing the Clinical Study Documentation
in collaboration with the Study Team members
- Preparing and completing the applications for the
regulatory authority and ethics committees
- Coordinating and being responsible for the completion
of study documentation material
- Preparing and conducting pre-study activities,
selection and initiation visits, routine monitoring and
closure visits
- Ordering and organising study supplies
- Preparing study documentation and assisting the
Clinical Quality Assurance Manager and regulatory
authorities during audits or inspections in-house or
on site
- Selecting and negotiating contracts with local/central
laboratories, pharmacies, etc.
- Planning, participating and leading Investigator's
Meetings.
-Suitable academic education in life sciences or
equivalent experience
-At least three years’ experience as CRM
-Strong organisational skills
-Good coaching skills
-A service-minded approach to your work
-Good team skills when working in large project
groups and study teams
-Solid communication and teaching skills
-Ability to prioritise and handle several tasks
simultaneously
-Experience with IT aids and PCs
-Able to express yourself both verbally and in writing.
A clinical research manager (CRM) works in the planning, execution and completion
of both national and international clinical trials. The work often involves cooperation
with colleagues at our other offices.