Company: Skills Alliance
Closing Date: 12 Dec 16
Salary (£): 60,000 - 80,000
Radek Weichert at Skills Alliance is recruiting for a Study Start-up Associate / SSU Specialist with focus on sites in Norway to join a Global CRO,...
Radek Weichert at Skills Alliance is recruiting for a Study Start-up Associate / SSU Specialist with focus on sites in Norway to join a Global CRO, working home or office based in Denmark (Copenhagen) on a permanent basis. One of very few companies on the market that offer work life balance.
You'll be accountable for:
Quality deliverables in Norway and Denmark for site start-up.
Forecasting submission/approval timelines and ensuring they are adhered to.
Essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
Tracking site recruitment and approvals according to study timelines
Ensuring accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to maintenance for filing in TMF
Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees and other local bodies.
Setting up and maintaining a country folder with country Ethics Committees and local authority addresses and requirements
Documenting QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client
You'll need this to be considered:
BSc, MSc or equivalent
Prior experience in Clinical Research with experience in start-up activities
Prior experience using computerized information systems preferred
Ability to read, write, and speak in English, Norwegian and Danish.
Clinical trials support or pharmaceutical industry experience preferred
Knowledge of ICH and local regulatory authority drug research and development regulations preferred
Salary and benefits: Very competitive
Please contact Radek Weichert with the latest version of your CV on: Radek.Weichert @ skillsalliance.com or call for confidential discussion on: +44 20 7220 6238
Senior CRA / SCRA / Senior Clinical Research Associate / Lead CRA / LCRA / Monitoring /Monitor / Clinical Trial / Drug Trial / Trial Sites / Clinical / CRA 1 /CRA 2 / ICH-GCP / Clinical Research / Clinical Trials / Study Start-Up / Start-Up / Study Start Up / SSU / Clinical Study Start-Up/ Clinical Study Start Up / Clinical Study Startup / Regulatory Affairs / Regulatory Documents / ICH-GCP /Senior CRA / SCRA / Senior Clinical Research Associate / Lead CRA / LCRA / Monitoring / Monitor / Clinical Trial / Drug Trial / Trial Sites / Clinical / Home Based / Home-Based / Clinical Research / Denmark / Sweden / Copenhagen / Arhus / Jutland / Norway / Norwegian / Oslo / Bergen / Trondheim / Submissions Specialist /
10 Aldersgate Street, London
|Tel:||+44 20 7220 6200|
|Fax:||+44 870 831 1705|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.