At a Glance
- Tasks: Lead study startup processes and ensure smooth project initiation in the UK.
- Company: Join PSI, a top Contract Research Organisation with 30 years of industry experience.
- Benefits: Enjoy a hybrid work model, professional development, and a supportive team environment.
- Other info: Great opportunity for growth in a dynamic and innovative company.
- Why this job: Make a real impact in clinical research while advancing your career.
- Qualifications: 4+ years in clinical research and 3+ years in study startup required.
The predicted salary is between 45000 - 55000 £ per year.
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.
Qualifications 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 Make the right call and take your career to a whole new level.
Join the company that focuses on its people and invests in their professional development and success. Summary
- Type: Full-time
- Function: Administrative Experience level: Mid-Senior Level
- Industry: Pharmaceuticals
Senior Study Startup Specialist employer: PSI CRO
As a Remote Director of Business Development at our company, you will join a supportive and innovative team that prioritises employee well-being and professional growth. With a strong emphasis on collaboration and a commitment to making a difference in medical science, we offer a dynamic work culture, competitive benefits, and opportunities for career advancement, all while working from the comfort of your own home in the UK.
