Location: Leeds, United Kingdom
Closing Date: 10 Nov 16
Salary (£): Competitive
COVANCE UK - we are 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 offices in Leeds and Maidenhead. These are permanent full time office based roles. Interested? Apply here http://jobsearch.covance.com/jobs/1413554-Senior-Study-Start-Up-Specialist.aspx
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for our Early Clinical Development team, 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 Leeds, United Kingdom. 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.
About the Job
Within this position your duties will include:
- 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
To be successful in this position, you will need to be educated to Degree level (or equivalent) in health care/scientific field - preferred, but not mandatory.
Additionally, you will need to demonstrate:
- Advanced understanding of study objectives, study procedures and project related timelines
- Comprehensive knowledge of the clinical trial process, preferably with early clinical pharmacology Experience
- 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 .
The opportunity to work within an Experienced and highlyskilled team.
Covance offers a comprehensive benefits package including health cover, contributory pension and a competitive bonus scheme Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality.
We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a
flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
There is no better time to join us!
Leeds, United Kingdom
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