Parexel Local Study Associate Director – FSP Recruitment 2026: Apply Online for Various Vacancies
Local Study Associate Director – FSP
Job Overview
About the Role
The Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at the country level to deliver committed components of clinical studies according to agreed resources, budget, and timelines. This role ensures full compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. The LSAD may also perform site monitoring as needed to support the flexible capacity model of the Functional Service Provider (FSP) division.
Key Operational Areas
The LSAD is responsible for ensuring that clinical trial sites are properly identified, qualified, set up, initiated, monitored, closed, and that all essential documentation is archived. This involves leading a dedicated team of Clinical Research Associates (CRAs) and Clinical Study Assistants (CSAs) to achieve high-quality data delivery within the specified country.
Strategic Impact and Collaboration
In this role, you will collaborate closely with global study teams, local medical affairs, and external stakeholders such as National Lead Investigators. By managing risks proactively and maintaining an inspection-ready electronic Trial Master File (eTMF), the LSAD plays a critical role in bringing innovative, life-saving therapies to market efficiently.
Key Job Details
| Company Name | Parexel |
| Job Role | Local Study Associate Director – FSP |
| Experience | Minimum 3 years of experience in Development Operations (CRA, SrCRA) or related fields |
| Salary Range | Not Disclosed |
| Job Type | Private |
| Work Mode | Remote / Home-based |
| Openings | Various |
| Job Location | Ontario, Canada (Remote) |
Key Responsibilities
- Lead and optimize the performance of the Local Study Team (consisting of CRAs and CSAs) at the country level.
- Coordinate the site selection process, perform initial Site Quality Risk Assessments, and conduct Site Qualification Visits.
- Oversee and coordinate monitoring activities from site activation through to study closure.
- Review monitoring visit reports and advise monitors on study-related matters.
- Ensure timely preparation of country-level Master Informed Consent Forms (MICF) and site-level ICFs.
- Maintain the completeness of the eTMF to ensure it remains ‘Inspection Ready’ at all times.
- Manage country-level study budgets, financial agreements, and ensure accurate payments according to local regulations.
- Proactively identify risks and facilitate the resolution of complex study problems and issues.
Requirements & Qualifications
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or related clinical research fields.
- Good knowledge of international guidelines (ICH-GCP) and relevant local clinical trial regulations.
- Bachelor’s degree in a life science discipline or equivalent qualification.
- Ability to travel nationally and internationally as required by study needs.
- High integrity, ethical standards, and a patient-centric mindset.
Required Skills
- Proven ability to lead, motivate, and manage cross-functional teams.
- Excellent project management and organizational skills.
- Strong interpersonal, communication, and negotiation capabilities.
- Excellent attention to detail and ability to prioritize multiple tasks.
- Proficiency in written and spoken English, along with fluency in the local language.
- Adaptability to work efficiently with advanced clinical trial IT systems.
About Parexel
Parexel is a leading global clinical research organization (CRO) that provides a comprehensive suite of biopharmaceutical services to help clients transform scientific discoveries into new treatments for patients. With a compassionate, collaborative, and results-driven culture, Parexel is dedicated to putting patients at the heart of clinical development.
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