Local Study Associate Director- FSP in Canada Creek, Nova Scotia at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps.

Our partner is looking for a Local Study Associate Director – FSP based in Canada.

This role is a key leadership position within clinical study operations, responsible for driving the successful execution of clinical trials at country level. You will oversee local study teams and ensure that all study activities are delivered on time, within budget, and in compliance with international regulatory standards and Good Clinical Practice (ICH-GCP). Acting as the central point of coordination for site management, you will lead site selection, activation, monitoring, and close-out activities while maintaining strong relationships with investigators, vendors, and global stakeholders. The role requires a high level of operational excellence, strategic oversight, and the ability to manage multiple priorities in a highly regulated environment. You will also contribute to risk management, study planning, and continuous process improvement, playing a direct role in enabling successful clinical development outcomes that ultimately support patient care.

• Lead and coordinate Local Study Teams to ensure successful delivery of clinical trial commitments at country level, including timelines, quality standards, and regulatory compliance.
• Oversee end-to-end site management activities, including feasibility assessment, site selection, qualification, initiation, monitoring, and close-out.
• Ensure adherence to ICH-GCP guidelines, sponsor procedures, and applicable local and international regulatory requirements.
• Manage study execution in CTMS and ensure accurate documentation, reporting, and maintenance of inspection-ready trial files (eTMF).
• Act as the primary operational leader for assigned studies, ensuring timely communication of progress, risks, and issues to global study stakeholders.
• Coordinate and oversee monitoring activities, including review of reports and support for CRA teams through training, coaching, and co-monitoring visits.
• Develop and maintain risk management plans, proactively identifying and mitigating study-related operational risks.
• Support regulatory submissions, ethics/IRB approvals, and study start-up activities in collaboration with regulatory affairs teams.
• Manage study-related budgets, contracts, and site payments in accordance with local requirements and sponsor agreements.
• Contribute to patient recruitment strategies and maintain strong engagement with investigators and site staff.
• Lead audit and inspection readiness activities, ensuring full compliance with quality and governance standards.
• Participate in cross-functional collaboration with medical, regulatory, and operational teams to ensure study alignment and success.

• Minimum 3 years of experience in clinical development operations, including CRA, Senior CRA, or equivalent roles within clinical research or related environments.
• Strong knowledge of ICH-GCP guidelines and clinical trial regulatory requirements at both local and international levels.
• Proven ability to lead cross-functional teams and manage complex clinical study operations in a fast-paced environment.
• Experience in site management activities, including feasibility, site activation, monitoring oversight, and study close-out.
• Strong project management, organizational, and multitasking skills with attention to detail.
• Excellent communication and interpersonal skills, with the ability to build strong relationships with investigators, vendors, and internal stakeholders.
• Strong problem-solving skills with the ability to identify risks and implement effective mitigation strategies.
• Proficiency in English (written and spoken) and fluency in local language(s) is required.
• Familiarity with CTMS, eTMF systems, and clinical trial documentation processes.
• Bachelor’s degree in life sciences or related discipline, or equivalent relevant qualification.
• Ability to travel nationally and internationally as required.
• Strong ethical standards, integrity, and commitment to compliance in a regulated environment.

• Competitive compensation aligned with senior clinical operations responsibilities.
• Remote-based role with flexibility and occasional travel requirements.
• Opportunity to lead impactful clinical trials contributing directly to advancements in patient care.
• Exposure to global clinical development programs and cross-functional international teams.
• Strong focus on professional development, training, and leadership growth.
• Work within a highly regulated, quality-driven environment with global standards.
• Collaborative culture focused on scientific excellence, ethics, and operational rigor.
• Opportunity to influence process improvements and operational best practices.