Study Start-Up Specialist - Freelance - Turkey
2 days left
- Experience Level
- Experienced (non-manager)
i-Pharm is urgently seeking on behalf of a Top Global CRO, a Freelance SSU Specialist. Our client is seeking a qualified professional with at least 5 years in the industry and is experienced in submissions and contract negotiation in Turkey.
- Responsible for the quality deliverables at the country level; follow project requirements and applicable country rules, with moderate oversight from the SSU Country Manager.
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed-upon SSU tracking system in real-time; if forecasted timelines are not reached: investigates and provides a clear rationale for delays, provides support on a contingency plan to mitigate the impact, and escalates the issue as soon as identified.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) promptly, keep training records updated accordingly and ensures timesheet compliance.
- Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Turkey - Home-based
Competitive Hourly Rate
- Bachelor's degree in a scientific discipline or equivalent
- 5 years of relevant experience
- Understanding of clinical trial process across Phases II-IV and ICH GCP.
- Understand clinical protocols and associated study specifications.
- Understanding of clinical trial start-up processes
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 Robert Zevallos on +44 (0)203 189 0486, or email firstname.lastname@example.org. If this role is not suitable, Robert is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
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