Study Director for Local Clinical Trials
1 week ago
Job Summary
Parexel is seeking a highly skilled Study Director to lead our local clinical trials team in Canada. As a key member of our team, you will be responsible for ensuring the successful delivery of committed components of clinical studies according to agreed resources, budget, and timelines.
About the Role
The Study Director will lead a team of professionals to deliver clinical trials from site activation through to study closure at country and site level in accordance with the Monitoring Plans. Key responsibilities include:
- Leading cross-functional teams to deliver clinical trials on time, within budget, and with required quality
- Developing and implementing project management plans to ensure timely delivery of data to required quality
- Collaborating with global stakeholders to ensure compliance with client Procedural Documents, ICH-GCP, and local regulations
- Identifying and mitigating risks to ensure successful trial delivery
- Coordinating site selection, qualification, and monitoring activities
- Ensuring timely preparation and submission of application/documents to EC/IRB and Regulatory Authority
- Managing budgets, agreements, and payments related to the study
- Maintaining accurate study documentation and ensuring compliance with Sponsor Standards and Parexel Standards
Requirements
To be successful in this role, you will need:
- A minimum of 3 years of experience in Development Operations (CRA, SrCRA) or other related fields
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations
- Excellent project management skills, including experience leading cross-functional teams
- Strong communication and interpersonal skills, with ability to build relationships with global stakeholders
- Ability to travel nationally and internationally as required
Benefits
Parexel offers a competitive salary range of $120,000 - $180,000 per annum, depending on experience. In addition, we offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
About Parexel
Parexel is a leading global biopharmaceutical services company that provides end-to-end solutions for clinical development, commercialization, and market access.
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