Our client is a leading global drug development services company that provides support to the Pharmaceutical and Biotechnology industries. They are recruiting for their Early Clinical Development team, and currently seeking to hire a (Senior) Study Start Up Specialist to perform local start up activities (EC/CA submissions, contract negotiations, start up document processing) in our office in Paris, France This is a permanent, full time, office based position.
The Senior Site Specialist may also be required to assist with the coaching and mentoring of colleagues in the drug development process and to act as a subject matter expert for all aspects of start up and maintenance of clinical trial records in eTMF and CTMS.
- EC (and CA, if applicable) submission compilation and processing, including ICF adaptation and preparation of applications.
- Site contract and budget negotiations
- Achieving site activation within set timelines and budget
- Multi Country Project responsibility (3 countries and 10 sites) may be required for senior position
- Implementation, optimized site activation timelines, risk management regarding communication, coordination, and quality.
- Supporting Planning & Forecasts
- Site Document Maintenance
Education, Skills and Experience:
- You will need to be educated to Degree level (or equivalent) in health care/scientific field - preferred, but not mandatory.
- Advanced understanding of study objectives, study procedures and project related timelines
- Comprehensive knowledge of the clinical trial process, preferably with early clinical pharmacology
- Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
- Ability to develop accurate study related documents with minimal supervision
- Comprehensive knowledge of GCP/ICH
- Good verbal and written communication skills in a local language and English
- Demonstrated organizational skills and the ability to prioritize multi-tasks
- Robust relevant research Experience
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.