Project Director - Clinical Study Management
Alimentiv
Summary
We are seeking an experienced clinical research professional to oversee the successful execution and delivery of clinical projects within an assigned region. This role serves as a key point of contact for sponsors, providing project oversight and ensuring clinical studies are delivered on time, within budget, and in accordance with quality and regulatory requirements. The successful candidate will work closely with Clinical Project Managers (CPMs), cross-functional teams, and external vendors to support project planning, resource management, and operational performance. This position also contributes to business development initiatives, team development, and continuous process improvement to ensure consistent, high-quality project delivery.
Job description
Job Overview
We are seeking an experienced clinical research professional to oversee the successful execution and delivery of clinical projects within an assigned region. This role serves as a key point of contact for sponsors, providing project oversight and ensuring clinical studies are delivered on time, within budget, and in accordance with quality and regulatory requirements. The successful candidate will work closely with Clinical Project Managers (CPMs), cross-functional teams, and external vendors to support project planning, resource management, and operational performance. This position also contributes to business development initiatives, team development, and continuous process improvement to ensure consistent, high-quality project delivery.
Key Responsibilities
- Serve as the primary regional representative for clinical projects, ensuring successful execution and delivery in alignment with sponsor expectations, timelines, budgets, and quality standards.
- Establish and maintain strong sponsor relationships, ensuring effective communication, timely resolution of issues, and alignment on project expectations and deliverables.
- Oversee clinical project planning, implementation, and execution in collaboration with Clinical Project Managers and cross-functional teams.
- Review and approve project scope, budgets, timelines, performance metrics, resource requirements, and training plans to ensure successful project delivery.
- Monitor project progress, critical paths, risks, and performance indicators, providing guidance to Clinical Project Managers to address challenges and maintain project quality.
- Ensure clinical projects comply with Standard Operating Procedures (SOPs), regulatory requirements, corporate guidelines, and industry best practices.
- Oversee project forecasting, resource allocation, and staffing requirements to ensure appropriate support for current and upcoming clinical projects.
- Monitor internal team and third-party vendor performance, ensuring services consistently meet sponsor expectations and project requirements.
- Support team management activities, including recruitment, performance evaluations, employee training, development, and departmental budget planning.
- Contribute to business development activities, including proposal development, Requests for Proposals (RFPs), bid defenses, and prospective client engagement.
Skills & Qualifications
- Minimum of 7 years of relevant professional experience in clinical research or a related field, supported by ongoing professional training and development.
- A three-year advanced college diploma or degree in a relevant discipline, preferably Health Sciences, Clinical Research, or a related field.
- Strong understanding of clinical project planning, execution, oversight, and delivery within established quality and regulatory requirements.
- Demonstrated ability to establish and maintain collaborative relationships with sponsors, internal stakeholders, and cross-functional project teams.
- Excellent verbal and written communication skills, with the ability to communicate project updates, risks, and expectations clearly and effectively.
- Strong organizational skills and attention to detail, with the ability to monitor multiple project priorities, timelines, and deliverables.
- Ability to assess project requirements, identify potential risks, resolve issues, and support effective decision-making to achieve positive outcomes.
- Strong leadership and team management capabilities, with the ability to foster teamwork, support employee development, and promote accountability.
- Self-motivated and results-oriented, with a demonstrated commitment to delivering high-quality services and achieving project objectives.
- Commitment to continuous learning, professional development, and improving operational processes and team performance.
Requirements
- Minimum of 7 years of relevant professional experience in clinical research or a related field
- Three-year advanced college diploma or degree in a relevant discipline, preferably Health Sciences, Clinical Research, or related field
- Strong understanding of clinical project planning, execution, oversight, and delivery within quality and regulatory requirements
- Demonstrated ability to establish and maintain collaborative relationships with sponsors, internal stakeholders, and cross-functional project teams
- Excellent verbal and written communication skills
- Strong organizational skills and attention to detail
- Ability to assess project requirements, identify risks, resolve issues, and support decision-making
- Strong leadership and team management capabilities
- Self-motivated and results-oriented
- Commitment to continuous learning and professional development
Benefits
- Education Reimbursement
- Cell Phone & Remote Work Allowance
- Office Setup Allowance
- Working While Visiting Program
- Flexible Summer Hours
- Employee Referral Incentive
- Alimentiv Trust Benefits
- Mentorship Program
- Annual Social Events
- Leadership Development Programs
- Short-Term Incentive Plan
Company overview
Alimentiv is a leading specialty gastrointestinal (GI) contract research organization (CRO) founded in 1986 and headquartered in London, Ontario, Canada. The company operates as a full-service CRO specializing in GI clinical trials, with deep expertise in inflammatory bowel disease (IBD), eosinophilic gastrointestinal diseases (EGIDs), celiac disease, and other GI disorders. Alimentiv provides comprehensive clinical research services including clinical trial management, medical monitoring, medical imaging solutions, precision medicine/biomarker services, histopathology, biostatistics, and real-world evidence generation. The company supports over 70% of all IBD compounds currently in development and maintains a global network of 5,000+ clinical trial sites across more than 60 countries. With approximately 501-1,000 employees and offices in Canada, the United States, Europe, and Australia, Alimentiv combines academic excellence with operational expertise to accelerate drug development timelines and improve clinical trial outcomes for pharmaceutical and biotechnology partners.