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Senior Study Startup Specialist
Company Description
PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
Take your career to the next level and be involved in study startup processes in the UK. You will provide direct operational support to project teams, ensure that clinical projects start smoothly and on time and support PSI in developing the local study startup team.
This role is hybrid with 2 days based in our Oxford office.
- Perform study startup activities and support all processes critical for site activation.
- Collect site documents for IRB/IEC submission and/or IP-RED process.
- File study-specific documentation in TMF, in accordance with Document management plan.
- Compile IP-REDs packages assuring high quality.
- Review study-specific translations, including patient-facing documents.
- Facilitates site agreement and/or budget negotiations with sites to ensure alignment to the site activation plan.
- Ensure initial distribution of locally obtained clinical study supplies to sites and supervise initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.
- Identify project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.
- Develop site-specific startup timelines and is responsible for meeting the site activation targets under supervision.
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Qualifications
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- College/University degree or an equivalent combination of education, training and experience
- At least 4 years' experience in clinical research
- At least 3 years of full-scope Study Startup experience
- Excellent knowledge of ICH GCP, local laws and applicable regulations in the region
- Full working proficiency in English
- Communication and organisational skills
- Ability to negotiate and build relationships at all levels
Additional Information
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