Local Study Associate Director – FSP

This is a fully remote position, open to applicants in Canada.

📋 Description

• The Local Study Associate Director (LSAD) is responsible for leading Local Study Team(s) (LSTs) at the country level to ensure the delivery of clinical study components within the agreed-upon resources, budget, and timelines, while adhering to Client Procedural Documents, international guidelines such as ICH-GCP, as well as applicable local regulations.

• Ensures the identification of sites, performs site qualifications, and oversees the setup, initiation, monitoring, closure, and archiving of documentation.

• Leads the Local Study Team, which includes CRA(s) and CSA(s), for designated study/studies.

• Facilitates the site selection process by identifying potential sites and investigators, conducting initial Site Quality Risk Assessments, and performing Site Qualification Visits to assess suitability and quality risks.

• Oversees, manages, and coordinates monitoring activities from site activation to study closure at both country and site levels in accordance with the Monitoring Plans.

• Actively fosters positive relationships with all Local Study Team members, site staff, and global stakeholders.

• Contributes to the patient recruitment strategy, which includes regular communication with participating Investigators as needed.

⛳️ Requirements

• A minimum of 3 years of experience in Development Operations (CRA, SrCRA) or other related fields, including Medical Affairs-led or Academic-led studies.

• Strong understanding of international guidelines such as ICH GCP and relevant local regulations.

• Demonstrated ability to lead and inspire cross-functional teams to deliver clinical trials on or ahead of schedule, within budget, and with the required quality.

• Exceptional project management skills.

• Strong team-building and interpersonal skills.

• Outstanding organizational abilities.

• Excellent verbal and written communication skills.

• Strong capability to prioritize and manage multiple tasks effectively.

• Keen attention to detail.

• Proficiency in written and spoken English is required.

• Fluency in local language(s) is required.

🏝️ Benefits

• Opportunities for professional development.

• Flexible working hours.