Cpl Life Sciences

Study Start Up Specialist (Amsterdam)

14 Jun 2021
13 Jul 2021
George Danchie
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)

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.

Key Responsibilities:

- 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.

Experience Required:

- 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.

Similar jobs

Similar jobs