Reference Number: JO-2106-470419
Study Start Up Specialist (Amsterdam)
Job Type: Permanent
Clinical Study Start Up Specialist/Senior Clinical Start Up Specialist
Home Based – Netherlands
Competitive Salary + Benefits
We are looking for experienced Study Start Up Specialists to join a global Clinical Research Organisation on a permanent basis. Reporting directly into a Senior Clinical Operations Manager, you will beaccountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. You will also support protocol amendments if applicable. You will focus on Netherlands County Feasibility and Netherlands Ethics Committee submissions.
– Main point of contact for the generation of country/site plans and the Study Start Up queries
– Build relationships with investigators and site staff for the management of Qualification follow-up/ site issues, site training, supplies and investigator site file set up.
– Attend Site Initiation Visits
– Customize and review, site specific Informed Consent Forms (ICF) and customize and negotiate any amendments.
– Develop strategy to manage quality country specific and/or site specific documents or essential regulatory documents and amended regulatory documentation.
– Minimum 18 months study start up experience working in the CRO environment
– Must have strong EC submission experience
– Advanced level knowledge and use or IRAS system/Amendment tool.
– Client focused approach
– Strong written and communication skills
– Ability to multi-task with good time management skills
The successful applicant will be rewarded with an attractive basic salary and benefits and a supportive working environment. This role can be part office based in Amsterdam or fully home-based across the Netherlands
If this role is of interest, please send your cv to George.Danchie@cpl.com or call 0118 959 4990 for further information.