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Study Startup specialist I - Job Opportunity at PSI CRO

Oxford, GB
Full-time
Entry-level
Posted: June 25, 2025
Hybrid
Based on the entry-level requirements, Oxford location, and specialized CRO environment, this position likely offers £28,000-£35,000 annually, which aligns with UK market rates for junior clinical research positions in pharmaceutical services companies, with potential for rapid progression given PSI's growth trajectory and selective project focus.

Benefits

Hybrid work arrangement offering flexibility with 2 days per week in-office requirement, providing better work-life balance compared to traditional full-time on-site positions
Opportunity to work within a growing company that emphasizes people-focused culture, potentially offering better job security and internal advancement opportunities
Access to global pharmaceutical industry exposure through PSI's international clinical trial operations across multiple countries and continents
Professional development in a specialized CRO environment with over 25 years of established industry reputation and selective project portfolio

Key Responsibilities

Drive critical site activation processes that directly impact clinical trial timelines and pharmaceutical development success, positioning you as a key contributor to drug development milestones
Support strategic feasibility research and site identification processes that determine the success and efficiency of multi-million dollar clinical trials
Maintain comprehensive study-specific and corporate startup tracking systems that serve as the operational backbone for clinical trial management and regulatory compliance
Facilitate complex site budgets and contract negotiations, developing critical business acumen and stakeholder management skills essential for career advancement
Coordinate site regulatory document collection processes that ensure compliance with international pharmaceutical regulations and maintain trial integrity
Prepare initial submission dossiers to competent authorities and ethics committees under supervision, gaining direct exposure to regulatory affairs and submission processes
Serve as primary communication liaison between project teams and investigational sites throughout the study startup phase, building essential relationship management and coordination skills
Develop site-specific startup timelines and enrollment projections while maintaining accountability for meeting site activation milestones, demonstrating project management capabilities
Review study-specific translations to ensure regulatory compliance across international markets, gaining valuable experience in global clinical operations
Supervise Trial Master File (TMF) maintenance throughout the study startup phase, ensuring comprehensive documentation standards that support regulatory inspections and audit readiness

Requirements

Education

Bachelor's degree or above, preferred in pharmaceutical/healthcare related majors

Experience

At least 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience in the country/region

Required Skills

Excellent communication skills, both written and verbal Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)
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Sauge AI Market Intelligence

Industry Trends

The clinical research industry is experiencing unprecedented growth driven by increased pharmaceutical R&D spending, with global clinical trial market projected to reach $69.8 billion by 2027, creating strong demand for study startup specialists who can efficiently navigate complex regulatory landscapes and accelerate trial initiation timelines. Digital transformation in clinical trials is reshaping study startup operations, with increased adoption of electronic systems for site selection, regulatory submissions, and trial master file management, making technical proficiency and adaptability crucial skills for advancement in this field. Post-COVID regulatory flexibility and decentralized trial models are creating new opportunities for study startup specialists to work with hybrid and remote site management approaches, requiring enhanced communication skills and digital collaboration capabilities that align with this role's hybrid work structure.

Role Significance

Study startup specialists typically work within cross-functional teams of 8-12 professionals including clinical project managers, regulatory affairs specialists, biostatisticians, and medical monitors, with direct collaboration with 3-5 investigational sites per study and reporting to senior startup managers or clinical operations directors.
This is a junior-level specialist position that serves as a critical entry point into clinical research operations, with significant exposure to multiple functional areas including regulatory affairs, site management, and project coordination, providing a comprehensive foundation for career advancement within the CRO industry.

Key Projects

Multi-phase clinical trials for pharmaceutical and biotechnology companies across various therapeutic areas including oncology, cardiovascular, and rare diseases International regulatory submission projects requiring coordination with multiple health authorities including MHRA, EMA, and FDA Site feasibility assessments and selection processes for global clinical trials spanning 10-25 investigational sites across multiple countries Regulatory compliance initiatives ensuring adherence to ICH-GCP guidelines and local regulatory requirements across diverse geographical regions

Success Factors

Developing exceptional attention to detail and organizational skills is crucial for managing complex regulatory documentation and maintaining comprehensive trial master files that must withstand regulatory inspections and audits. Success requires the ability to systematically track multiple parallel processes while ensuring nothing falls through administrative gaps that could delay critical trial milestones. Building strong interpersonal and communication skills to effectively coordinate between diverse stakeholders including clinical investigators, site coordinators, regulatory authorities, and internal project teams across different time zones and cultural contexts. The ability to diplomatically resolve conflicts and maintain positive relationships directly impacts site activation timelines and overall project success. Mastering regulatory knowledge and staying current with evolving guidelines across multiple jurisdictions is essential for preparing compliant submission dossiers and advising sites on regulatory requirements. This includes understanding country-specific variations in ethics committee processes, competent authority requirements, and local clinical trial regulations that can significantly impact startup timelines.

Market Demand

High demand exists for study startup specialists as pharmaceutical companies increasingly outsource clinical operations to specialized CROs, with particular strength in the UK market due to its favorable regulatory environment post-Brexit and established pharmaceutical industry presence, creating competitive opportunities for qualified candidates.

Important Skills

Critical Skills

Excellent written and verbal communication skills are absolutely essential because this role requires constant interaction with investigational sites, regulatory authorities, and internal stakeholders across multiple time zones and cultural contexts. The ability to clearly communicate complex regulatory requirements, negotiate timelines, and resolve conflicts directly impacts study startup success and can mean the difference between meeting critical milestones or experiencing costly delays that affect the entire clinical development program. Proficiency in MS Office applications, particularly Excel for tracking systems and PowerPoint for stakeholder presentations, forms the technological backbone of study startup operations. Advanced Excel skills for creating and maintaining complex tracking spreadsheets, PowerPoint expertise for presenting feasibility data and startup timelines, and Outlook proficiency for managing extensive email communications with multiple stakeholders are daily requirements that directly impact operational efficiency. Strong organizational and project management capabilities are crucial for simultaneously managing multiple study startup activities, regulatory submission deadlines, and site activation milestones across different therapeutic areas and geographical regions. The ability to prioritize competing demands, maintain detailed documentation systems, and proactively identify potential delays requires exceptional time management and systematic thinking skills.

Beneficial Skills

Knowledge of regulatory guidelines such as ICH-GCP, FDA regulations, and EMA guidelines would significantly accelerate performance and career advancement, as understanding these frameworks enables more effective regulatory strategy development and submission preparation, making candidates more valuable for complex international studies. Experience with clinical trial management systems (CTMS) and electronic document management systems would provide competitive advantage, as the industry continues digital transformation and companies seek candidates who can quickly adapt to new technologies and optimize electronic workflows for improved efficiency. Foreign language skills, particularly European languages, would be highly valuable given PSI's international focus and Swiss origins, enabling direct communication with investigational sites and regulatory authorities across multiple countries without requiring translation services or intermediaries.

Unique Aspects

This role offers exceptional breadth of exposure across multiple critical clinical research functions including regulatory affairs, site management, feasibility, and project coordination, providing a comprehensive foundation that many specialized positions cannot match and creating multiple career pathway options.
The combination of PSI's selective project approach and global reach means candidates will likely work on fewer but more complex and strategically important studies, providing deeper learning opportunities and more meaningful professional experience compared to high-volume CRO environments.
The hybrid work arrangement with only 2 days per week in-office requirement is particularly advantageous in the clinical research field, where many positions still require full-time office presence, offering better work-life balance while maintaining essential face-to-face collaboration for complex regulatory and site management activities.

Career Growth

Career progression typically occurs within 18-36 months for high-performing individuals, with opportunities for advancement accelerated by PSI's selective project approach and growing market presence, particularly for candidates who demonstrate exceptional regulatory knowledge and stakeholder management capabilities.

Potential Next Roles

Senior Study Startup Specialist or Study Startup Manager positions typically achieved within 2-3 years, involving greater autonomy in managing complex studies and mentoring junior staff Clinical Project Manager roles focusing on end-to-end study management, usually attainable within 3-5 years with demonstrated project leadership capabilities Regulatory Affairs Specialist positions leveraging regulatory submission experience gained in this role, particularly attractive for candidates interested in deeper regulatory focus Business Development roles within CROs for candidates who excel in client relationship management and demonstrate strong commercial acumen through site negotiations and feasibility work

Company Overview

PSI CRO

PSI CRO represents a well-established mid-tier contract research organization with over 25 years of pharmaceutical industry experience, originating from Switzerland and maintaining private ownership structure that often translates to more agile decision-making and employee-focused policies compared to large publicly-traded CROs. The company's selective project approach suggests they focus on higher-value, complex studies rather than competing primarily on volume, which typically provides employees with more intellectually challenging work and better learning opportunities.

PSI occupies a strong position in the mid-tier CRO market, competing effectively against larger organizations by offering more personalized service and specialized expertise, while maintaining global reach across multiple continents. Their 25-year track record and selective project approach indicate financial stability and established client relationships, providing job security and career development opportunities in a competitive but growing market segment.
The Oxford location positions this role within one of Europe's leading pharmaceutical and biotechnology hubs, offering access to a robust ecosystem of pharmaceutical companies, academic medical centers, and regulatory expertise. This geographic advantage provides networking opportunities, exposure to cutting-edge research, and potential career mobility within the broader UK life sciences sector.
PSI's emphasis on being 'highly selective about projects' and 'true focus on its people' suggests a quality-over-quantity work environment that likely offers better work-life balance and professional development compared to high-volume CROs. The hybrid work arrangement and people-focused messaging indicate a progressive approach to employee satisfaction and retention, which is particularly valuable in the competitive clinical research talent market.
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