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Study Startup Specialist I - Job Opportunity at PSI CRO

Mississauga, Canada
Full-time
Entry-level
Posted: June 6, 2025
Hybrid
CAD 45,000 - 55,000 annually based on entry-level positioning in the Canadian clinical research market. Mississauga's proximity to Toronto's pharmaceutical hub typically commands salaries 10-15% above national averages for similar roles. The hybrid work arrangement and established company reputation suggest competitive compensation within this range.

Benefits

Professional development investment programs that enhance career advancement opportunities and skill acquisition
Hybrid work arrangement providing flexibility and work-life balance while maintaining collaborative team dynamics
Stability of working with an established industry leader with over 28 years of market presence
Exposure to diverse therapeutic indications expanding professional expertise and marketability

Key Responsibilities

Drive critical site activation processes that directly impact study timeline success and client satisfaction, positioning yourself as a key operational enabler
Lead feasibility research and site identification initiatives that shape project strategy and determine study viability across target markets
Maintain comprehensive project tracking systems and electronic Trial Master Files ensuring regulatory compliance and audit readiness
Coordinate site agreements and budget negotiations that directly influence project profitability and stakeholder relationships
Orchestrate document collection and submission processes for regulatory bodies, ensuring seamless study approval workflows
Provide strategic progress updates to cross-functional teams, serving as a central communication hub for study startup activities
Identify and escalate project-specific challenges using established communication protocols, preventing potential delays and cost overruns
Prepare comprehensive study dossiers and regulatory packages that facilitate smooth regulatory submissions and approvals
Manage information exchange with investigational sites and vendors, ensuring seamless coordination across the study ecosystem

Requirements

Education

College/University degree or an equivalent combination of education, training and experience

Experience

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

Required Skills

Communication and organizational skills Ability to negotiate and build relationships at all levels
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Industry Trends

The clinical research industry is experiencing unprecedented growth driven by increased pharmaceutical R&D spending, with global clinical trials market expected to reach $69.8 billion by 2025. This growth is creating sustained demand for study startup specialists who can accelerate trial timelines and reduce operational bottlenecks. Digital transformation in clinical trials is reshaping startup processes, with electronic systems like eTMF becoming standard practice. Professionals skilled in digital trial management platforms are increasingly valuable as sponsors seek to leverage technology for efficiency gains. Regulatory harmonization initiatives across global markets are creating opportunities for specialists who understand multi-regional submission requirements. The ability to navigate complex regulatory landscapes is becoming a key differentiator in the CRO industry. Post-pandemic emphasis on hybrid and decentralized trial models is driving demand for startup specialists who can coordinate remote site activation and virtual oversight processes, making this skill set particularly valuable in the current market.

Role Significance

Typically operates within a study startup team of 3-5 specialists, reporting to a Study Startup Manager or Clinical Operations Manager. Interfaces regularly with cross-functional teams including clinical monitoring, regulatory affairs, and project management departments.
Entry-level specialist position serving as a foundational role in clinical operations hierarchy. While junior in level, the position carries significant operational responsibility for study timeline success and serves as a critical training ground for advancing into senior clinical operations roles.

Key Projects

Multi-site Phase II and III clinical trials across various therapeutic areas requiring complex site activation coordination Regulatory submission preparation for Health Canada and FDA approvals involving comprehensive documentation packages Site feasibility assessments for international sponsors looking to establish clinical trial presence in North American markets Audit preparation and documentation management for sponsor and regulatory authority inspections

Success Factors

Strong attention to detail and organizational capabilities are essential given the regulatory nature of clinical trials where documentation errors can result in significant delays and compliance issues. Excellent communication skills across multiple stakeholders including investigators, sponsors, regulatory bodies, and internal teams, as the role serves as a central coordination point for study startup activities. Adaptability and problem-solving abilities are crucial as each study presents unique challenges requiring creative solutions within regulatory constraints. Technology proficiency with clinical trial management systems and electronic documentation platforms, as digital transformation continues to reshape industry operations. Understanding of regulatory requirements and clinical trial processes, as this knowledge directly impacts the quality and efficiency of study startup activities.

Market Demand

High demand driven by robust clinical trial activity and industry expansion. Entry-level study startup roles serve as critical pipeline positions for CRO operations, with consistent hiring needs across major pharmaceutical markets.

Important Skills

Critical Skills

Organizational and project management capabilities are absolutely essential as study startup specialists must coordinate multiple parallel workstreams with strict regulatory deadlines. Failure to maintain organized systems can result in study delays costing sponsors millions of dollars and potentially compromising patient safety. Communication skills across diverse stakeholder groups are critical for success, as the role requires regular interaction with clinical investigators, regulatory authorities, internal teams, and sponsor representatives. The ability to clearly convey complex information and build professional relationships directly impacts operational efficiency. Attention to detail and quality focus are paramount in clinical research where regulatory compliance is non-negotiable. Small errors in documentation or process execution can trigger regulatory sanctions, audit findings, or study delays with significant financial and reputational consequences.

Beneficial Skills

Technology proficiency with emerging clinical trial platforms and artificial intelligence tools will become increasingly valuable as the industry continues digital transformation initiatives Basic understanding of Good Clinical Practice (GCP) guidelines and regulatory frameworks, while not explicitly required, would accelerate onboarding and professional development Foreign language capabilities, particularly French given the Canadian location, could provide advantages for international study coordination and broader career opportunities Data analysis skills for feasibility assessments and site performance evaluation are becoming more valued as sponsors seek data-driven decision making in site selection processes

Unique Aspects

Entry-level position offering comprehensive exposure to end-to-end study startup processes, providing accelerated learning opportunities typically reserved for more senior roles
Direct involvement in regulatory submission processes including IP-RED packages, offering valuable regulatory experience that enhances career versatility
Hybrid work arrangement in a traditionally office-based industry function, providing modern work-life balance while maintaining necessary collaboration
Opportunity to work across multiple therapeutic indications, building diverse clinical research expertise that increases marketability across pharmaceutical sectors

Career Growth

Typical progression to mid-level roles occurs within 2-3 years with strong performance, while advancement to senior management positions generally requires 5-7 years of progressive experience in clinical operations.

Potential Next Roles

Study Startup Manager or Senior Study Startup Specialist within 2-3 years, overseeing multiple studies and mentoring junior staff Clinical Project Manager roles focusing on end-to-end study management and client relationship oversight Regulatory Affairs Specialist positions leveraging regulatory submission experience gained in the startup role Business Development roles within CRO organizations, utilizing operational knowledge to support client acquisition efforts

Company Overview

PSI CRO

PSI CRO operates as an established mid-tier contract research organization with over 28 years of industry experience, positioning itself between boutique CROs and large multinational organizations. The company focuses on delivering specialized services across multiple therapeutic areas while maintaining the agility to adapt to client needs and market changes.

PSI holds a solid position in the competitive CRO landscape, competing effectively against both larger organizations and specialized boutique firms. The company's 28-year track record provides credibility with pharmaceutical sponsors while its focus on quality and innovation helps differentiate from commodity-focused competitors.
The Mississauga location strategically positions PSI within the Greater Toronto Area's life sciences corridor, providing access to major pharmaceutical companies, regulatory expertise, and a skilled talent pool. This location offers advantages for both North American and international clinical trial operations.
The company emphasizes professional development and employee investment, suggesting a culture focused on long-term employee growth rather than high-turnover operations common in some CRO environments. The hybrid work model indicates progressive workplace policies adapted to modern professional expectations.
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