Clinical Trial Start-Up Submission Specialist
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services.
Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.
We have an exciting internal opportunity for you to join the Site, Intelligence & Activation (SIA) on a permanent basis.
As a Country Approval Specialist, you will manage the preparation, review and coordination of country submissions in the UK.
This is an office based position and can be based in Cambridge, Glasgow or Winchester office. Main duties and Responsibilities include :
Prepare, review and coordinate local submissions to Regulatory and Ethics Committee required for clinical trial site approval in alignment with global submission strategy
Provide local regulatory strategy and advice
Act as a key contact on a country level for all submission related activities and provide oversight for projects
Coordinate, under guidance, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines
Oversight of the trial set-up and responsible for liaising with other functional roles within the start-up team such as Feasibility Specialists, Contract Specialists, Clinical Research Associates and Project Assistants.
Ideally experience in a study start-up, or experience with, regulatory documents in a clinical setting
University degree in a health / science-related will be an advantage
Deep knowledge in UK and Ireland Clinical Research Legislation
Understanding of ICH-GCP
Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Strong attention to detail
Effective communication and interpersonal skills
Good organizational and time management skills
Ability to work in a team or independently as required
Fluency in English both written and spoken
LI-EP1IndeedPPDEMEANW Additional Information
Requisition ID : 152932