Our Global Pharma client is seeking an experienced Clinical Trial Contracts Associate to cover a maternity contract for approximately 9-12 months. The ideal candidate must have previous experience reviewing the regulatory documents submission package^and the preparation, review, confirmation and distribution of the draft Clinical Trial Agreement and Budget to Site.
Duties:
Responsible for the logistical tasks associated with the preparation, collation and review of the regulatory document submission package.
Ensures distribution of draft essential documents to the selected sites. Responsible for drafting and reviewing of Study ICF.
Responsible for the developmentof the Country-specific Informed Consent templateby adapting the Study^ICF templates with country-specific requirements.
Confirms the documents for drug release are received in-house and follows-up with site if documents are missing or incomplete.
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.
Ensure follow-up with site if documentsare missing or incomplete.
Ensure the preparation of the final Clinical Trial Agreement and budget and route for signature.
Ensure the distribution of final documents as appropriate. Responsible for managing amendments to the CTAs as necessary.
Skills/Experience:
An Understanding of the role gained from previous experience in a clinical trials/ regulatory environment would be essential
Science Graduate preferred, but not essential if prior experience and skills are strong
Strong organisational skills and the ability prioritise in order to be flexible around the needs of the business
Team Player - actively contributes to meetings and able to give and receive feedback
Able to work on own initiative, and be proactive as issues arise
Detail oriented and accurate
Must have a good understanding of clinical study costs
Strong communication skills
Strong computer skills - Microsoft Office
Please apply online or send your CV directly to Michela@cslrecruitment.com
Key Words: Clinical Trial Contract, budgets, Clinical Trial Agreement, CTA, Regulatory, Submission, Berkshire, Buckinghamshire, Hertfordshire, Oxfordshire, Middlesex