SSU - Norway - 4 months - CRO - 0.5 FTE

The Clinical job market took a massive hit this time last year when the global COVID-19 pandemic was at large. Studies delayed, site closed and with people unable to travel it slowly came to a halt. A year on and the market has never been stronger, and ever growing.

Currently I am working closely an industry leading CRO who are looking to bring on a Freelance Study Start-Up Specialist for an initial 4-month contract. The home-based position, so it is ideal for those located anywhere across Norway or Sweden as long as you are experienced with Regulatory and EC submission for Clinical Trials in Norway.

THE ROLE

• Act as the client's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
• Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs), and any amendments.
• Carry out Start-Up activities from site identification through pre-initiation.
• Conduct, drive, and manage country-specific feasibility and/or site pre-qualification and qualification activities,
• Accountable for managing and driving the strategy for the Pre SIV / start-up tasks of the study.
• Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
• Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.

LOCATION

Norway/ Sweden

RATE

Competitive hourly rate

DURATION

4-month contract

0.5 FTE

REQUIRED

• Bachelor's degree in a scientific discipline or equivalent
• Minimum 2 years of Study Start-Uo experience
• Good understanding of both clinical trials methodology and terminology.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology, and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Robert Zevallos on +44 (0)203 189 0486, or email rzevallos@i-pharmconsulting.com. If this role is not suitable, Robert is also available to discuss other possible positions or answer any general questions regarding your career and the current market.