Study Start-Up Specialist - UK Wide
- Experience Level
- Experienced (non-manager)
Completing the enrollment of the first patient. Without delays, without mistakes.
This is what our Start-up Specialists live for: orchestrating the activities that will allow sites to be activated fast so they can immediately begin to screen patients.
And now, we have a new SSU Specialistjob open at our sponsor dedicated FSP team in the South East of England.
Covance has supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.
Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.
We can offer you not only a job, but a stable, long-term international career.
On a normal day, you will find yourself providing your expertise planning the whole process flow & timelines until Site Activation. We will trust you to be Covance´s main primary contact for sites and to drive the collection, tracking and quality review of all essential & investigator documents, ICF customization, etc. You will take ownership of the submissions to ECs and Agencies and we will need your wise input answering submission/approval issues. Lastly, you will be responsible for site contracts and budget negotiations.
From the initial project specific planning to Site Activation green light - that´s you.
To thrive in this job, you must:
- Be a site-relationship builder : you are experienced in getting sites to provide you with the documents you need on time (and with non-responsive sites, you know how to balance the "push" with being friendly)
- Be our ECs/Regulatory procedures Confident : when they raise submissions/ approval questions, you know how to ask, listen and really understand their need, and you know how to answer them in an exact and diplomatic manner too.
IS THIS YOU?
Our ideal candidate lives in the South East of England, and loves a client office environment
This is a full-time job.
Business proficiency in English- both spoken and written - is a must for the job.
University/College degree (life Science preferred), or certification in a health related profession from an accredited institution (e.g. nursing, medical or lab technology, etc . )
This is not an entry level position.
The person taking this job is expected to drive submissions to ECs and Agencies, site contracts and budget negotiations.
Solid and proven Site Start-Up experience in phase I to III clinical trials within the context of a CRO/ Pharmaceutical company environment, including deep working knowledge of ICH-GCP and , IRB/IEC regulations , is needed.