Hobson Prior are currently looking for an Associate Site Contract Leader to join a reputable Clinical Research Organisation. They aim to assist on the development journey to biopharmaceutical and medical devices worldwide. This role will manage the Clinical Site Agreement process for any given project.
- Lead projects and develop study specific CSA strategy.
- Ensure compliance with applicable ICH-GCP Guidelines and local regulatory requirements.
- Managing CSA tasks and communicating with SCL, PL, COL and the Sponsor to make sure that the CSA start-up are met.
- Assist site confidential disclosure agreements negotiations.
- Negotiate study specific generic and/or country CSA templates.
- Discuss and confirm specific country CSA templates with input from Sponsor, PL and/or COL.
- Store the final approved and complete country CSA template and country budget in PMED, along with the CSA approval form.
- Arrange with sites the respective CSA in accordance with the CSA strategy agreed with the Sponsor, CSA turnaround timelines, CTMS tracking requirements and budget negotiation parameters.
- Work within the defined “fallback” / approval parameters to manage / resolve significant CSA changes requested by the site.
- Keep PL/COL informed about CSA progress and any issues during the CSA negotiation.
- Sustain CSA negotiation status accurately tracked in CTMS.
- Excellent organizational, diplomacy, and team leadership skills.
- Excellent interpersonal, verbal and written communication skills.
- Ability to motivate both individuals and a team.
- Successfully work in a “virtual” team environment.
- Ability to complete tasks in an accurate and effective manner.
- Consistently performs high quality work.
- Capable of identifying issues efficiently.
- Work self-sufficiently and able to use own initiative.
- Excellent computer and internet skills including knowledge of MS- Office products.
- Experienced CRA, CMA, CTS or with a legal or business degree.
- Degree in business, legal or life science or within relevant work experience (Contracting, Clinical Operations or in Legal – Paralegal).
- Fluent in written and spoken English.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.