Site Activation (SSU) Team Manager
2 days left
- Experience Level
I-Pharm is urgently seeking on behalf of a Top Global CRO, a Freelance Senior Study Start-Up Project Delivery Manager. Our client is seeking a qualified professional with at least 6 years of industry experience, who is also able to take on management of Site Start-Up (SSU) deliverables within a region or globally. Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations
- Responsible for the management of site activation deliverables within a region or globally, within assigned projects.
- Collaborates with major functional area leads (SSU Country Managers, Project Management, and Clinical Management) to identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrolment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented
- Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
- Start-up regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses, study maintenance submissions)
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
- Performs other work-related duties as assigned.
Europe - Home Based
Competitive Hourly Rate
- Bachelor's degree in a scientific discipline or equivalent
- Minimum 6 years of industry experience
- Minimum 5 years' experience working in SSU
- Experience with at least one of the following trial types: paediatric, medical devices, bioequivalence, advanced therapy products, or vaccines.
- Experience with leading at least 10 studies from award and into maintenance; at least 3 of those studies must have included more than 15 countries across multiple regions
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology, and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, and Bioinformatics.
If you would like to discuss this vacancy further, please call Zara Linehan on +44 (0)203 189 0470, or email email@example.com. If this role is not suitable, Zara is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
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