Study Startup Specialist II

PSI CRO·Oxford, England, United Kingdom

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About the role

PSI seeks a Study Startup Specialist II in Oxford to lead country-level study activation activities. The role includes site document collection, IRB/IEC and IP-RED submissions, TMF filing, feasibility support, site agreement and budget negotiations, document coordination, clinical supply distribution, vendor communication, and meeting site activation targets. A Life Sciences degree or equivalent education, training and experience, at least two years of full-scope country/region study startup experience, and full working proficiency in English are required.

Key requirements

• College/University degree in Life Sciences or an equivalent combination of education, training and experience
• At least 2 years of relevant experience
• Required skills: Study startup activities, Site activation, IRB/IEC submission documentation, IP-RED package preparation and submission, Trial Master File (TMF) documentation, Feasibility research and site identification, Site agreement and budget negotiation, Study document translation and review, Issue identification and escalation, Clinical study supply distribution, Investigational product distribution coordination, Site, vendor and off-site facility communication, Startup timeline and enrolment projection development, English communication, Organizational skills, Relationship building and negotiation
• Required language: English

Opportunity details

• Posted: Sep 25, 2026
• Original advert language: English

Full vacancy

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Employer’s role description

Job title: Study Startup Specialist II

Location: Oxford, England, United Kingdom

Employment type: Full-time

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Job Description

Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.

You will:

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
Assist in feasibility research and site identification, upon request
Facilitate site agreement and budget negotiations
Coordinate translation and review of study-specific documents
Identify and escalate project-specific issues as needed
Prepare and submit IP-REDs packages
Ensure initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites
Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision

Qualifications

College/University degree in Life Sciences or an equivalent combination of education, training and experience
At least 2 years of full-scope Study Startup experience in the country/region
Full working proficiency in English
Well-developed communication and organizational skills
Ability to negotiate and build relationships at all levels

Additional Information

We offer:

Excellent working conditions
Extensive training and friendly team
Competitive salary and benefits package
Opportunities for personal and professional growth

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.