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Study Operations Manager II - FSP - Job Opportunity at Parexel

Ottawa, Canada
Full-time
Senior
Posted: January 18, 2025
Hybrid
CAD 110,000 - 140,000 annually based on Ottawa market conditions and role seniority

Benefits

Competitive healthcare package based on industry standards
Professional development opportunities through clinical research exposure
Global project exposure and international collaboration opportunities
Work-life flexibility with remote work options

Key Responsibilities

Lead and oversee clinical trial operations at regional/country level
Manage vendor relationships and ensure operational excellence in trial execution
Drive strategic planning and risk mitigation for clinical studies
Coordinate cross-functional teams and ensure regulatory compliance
Oversee site selection, activation, and management processes

Requirements

Education

Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience required OR Master's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required

Experience

6-7 years minimum depending on education level

Required Skills

Expertise in study and site dashboards and reporting tools Detail oriented and technical expertise Complex process management Risk identification and mitigation Strategic planning and critical path analysis Analytical and problem solving Adaptability to changing technologies Innovation leadership Effective communication Matrix management Fluency in English Ability to travel
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Sauge AI Market Intelligence

Industry Trends

Increasing adoption of decentralized clinical trials requiring new operational approaches Growing emphasis on risk-based quality management in clinical trials Rising demand for data-driven decision making in trial operations Shift towards integrated technology solutions for trial management

Role Significance

Typically leads a matrix team of 10-15 cross-functional members including CRAs, CTAs, and vendor staff
Senior management position with strategic influence on trial execution and operational excellence

Key Projects

Multi-country clinical trial implementations Site network development and management Vendor oversight programs Process optimization initiatives Quality management system implementations

Success Factors

Strong operational leadership with ability to influence without direct authority Excellence in stakeholder management across global teams Deep understanding of clinical research regulations and best practices Strategic thinking combined with tactical execution capabilities Proven track record in risk management and problem-solving

Market Demand

High demand driven by expanding clinical trial complexity and increasing regulatory requirements

Important Skills

Critical Skills

Clinical operations expertise with focus on multi-country trial management Vendor management and oversight capabilities Risk management and mitigation strategies Strategic planning and execution abilities

Beneficial Skills

Experience with decentralized trial technologies Change management capabilities Budget management experience Quality management system expertise

Unique Aspects

Strong focus on FSP (Functional Service Provider) model indicating strategic partnership approach
Emphasis on innovation and technology adoption
Global role with significant autonomy in regional operations
Balance of strategic and operational responsibilities

Career Growth

Typical progression to next level within 2-4 years based on performance and organizational growth

Potential Next Roles

Global Study Manager Clinical Operations Director Head of Clinical Operations Program Director

Company Overview

Parexel

Parexel is a leading global CRO with extensive experience in clinical research services

Top 5 global CRO with strong market presence and established reputation
Significant presence in Canadian market with growing operations in Ottawa
Matrix organization emphasizing global collaboration and operational excellence
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