Norway Country Study Manager

Country Study Manager Norway

We have a new opportunity for a homebased Study Manager in Norway

In this role, you are a Member of the Global Clinical Studies Team and the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and applicable local regulations.  You will also maintain the quality and scientific integrity of clinical trials at a country level.  In addition, you will collaborate with cross-functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country.

CSM key responsibilities include;

• Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)
• Accountable for study deliverables in that country.
• Leads country-level operational planning and supports site selection within assigned country(ies)
• Ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables 
• Ensure key stakeholders are kept informed of study progress e.g. global leads, global clinical project managers, etc.
• Ensure effective study risk management for assigned country(ies)
• Contribute to development of study-specific materials – e.g. monitoring plan, study specific training documents.
• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
• Oversight and monitoring of applicable vendor activities eg. laboratories and equipment provisioning
• Execute regulatory agency inspection readiness activities (e.g. TMF review, story board generation)
• Participate in cross-functional task forces/process improvement groups
• Identifying risk, implementing risk mitigation strategies and resolving issues at a country/site level
• Leading and continually reviewing country level risk mitigation activities to ensure study delivery to plan

You will need:

• University degree in Life/Health Sciences
• Minimum 3 years’ clinical trial management experience, ideally
• Minimum 3 years’ experience of leading local/regional or global teams
• 7 years’ work experience in life sciences or medically related field, including ideally 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)

Opportunities at ICON Global Strategic Solutions offer a competitive salary and benefits package with career scope. The position is full time and comes with a permanent contract of employment 100% dedicated to one sponsor. The role is fully homebased in Norway with no travel.

If you are open to discussing a new role, please apply and to arrange a call.