Freelance SSU Specialist - 6 months - 1.0 FTE

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.

THE ROLE

• 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.

LOCATION

Turkey - Home-based

RATE

Competitive Hourly Rate

DURATION

6-months

1.0 FTE

REQUIRED

• 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.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Robert Zevallos on +44 (0)203 189 0486, or email rzevallos@i-pharmconsulting.com. 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.

KEYWORDS

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