Our client, a specialist global pharmaceutical company and innovative leader in pharmaceutical and health care research and development, is mainly concerned with development activities. They are seeking a Study Start Up Specialist for their Buckinghamshire office.
The Study Start Up Specialist will develop, evaluate, and execute all essential clinical trial documents and clinical trial agreements (CTAs). They will align execution activities with agreed upon project priorities, timings and quality specifications.
PRINCIPAL RESPONSIBILITIES include:
Responsible for the logistical tasks associated with the preparation, collation and review of the regulatory documents submission package
Ensuring distribution of draft essential documents to the selected sites
Responsible for drafting and reviewing of Study ICF
Responsible for the development of the Country-specific Informed Consent template by adapting the Study ICF templates with country-specific requirements
Responsible for on-going regulatory document maintenance
Responsible for the preparation, review, confirmation and distribution of the draft Clinical Trial Agreement and Budget to Site
Responsible for the Negotiation with site on budget costs and contract language
Responsible for the review of the Clinical Study Registration Document against available study information Responsible for the posting the approved Clinical Study Registration Document to the appropriate clinical registry
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Degree, preferably in a science or health-related discipline
Previous experience of working in a clinical / regulatory contracts and negotiations role is preferred
PERSONAL SKILLS & ATTRIBUTES:
Excellent communication skills, both written and verbal
BENEFITS OF THE ROLE: This leading pharmaceutical company is committed to fostering a friendly work place with no discrimination. They offer competitive annual salaries together with excellent benefits that include Pension Plan, Life Assurance, Private Medical Insurance, Disability & Accident Insurance, good Annual Leave, Performance related Bonus, Free Car Parking, Subsidised Restaurant, Sports & Social and more.
Fforde is acting as a recruitment agency/business.
KEY WORDS: Study Start Up, Clinical Study, Clinical Studies, Clinical Trials, Clinical Monitoring, Clinical Research, Clinical Trial, Degree, Science, Healthcare, Pharmaceutical, Regulatory, Clinical, Pharmaceutical, Buckinghamshire, UK