Local Study Associate Director

Local Study Associate Director (Trial Manager - Oncology) ICON Strategic Solutions is seeking a Local Study Associate Director (Trial Manager - Oncology). This role has overall responsibility for study commitments within the country and for timely delivery of data to required quality. What You Will Be Doing Lead and optimize the performance of the Local Study Team(s) at country level, ensuring compliance with Procedural Documents, ICH-GCP and local regulations. Ensure high-quality feasibility assessments for potential studies when required. Coordinate site selection: identify potential sites/investigators, perform Site Quality Risk Assessments, and conduct Site Qualification Visits to evaluate suitability and quality risks. Ensure timely submission of applications/documents to EC/IRB at start-up and throughout the study; collaborate with Regulatory Affairs for submissions to Regulatory Authorities. Prepare and maintain country budget and Master CSA (including site budget); monitor financial reports in the AZ clinical studies financial system as agreed with leadership. Prepare local Master Informed Consent Forms (MICFs) and site-level ICFs, including translations, in line with SOPs and local regulations. Collect and verify country and site-level essential documents required by ICH-GCP prior to study start, and maintain readiness for enrolment. Plan and coordinate local drug activities (from purchase/reimbursement to destruction). Set up and maintain the study in CTMS at country level and ensure local websites comply with local laws and regulations. Oversee and coordinate monitoring activities from site activation to study closure; review monitoring visit reports and advise monitors on study-related matters. Perform co-monitoring and accompany site visits/trainings as needed. Identify risks proactively and facilitate resolution of complex study problems and issues. Organize regular Local Study Team meetings and maintain positive relationships with sites, staff, and global stakeholders. Report study progress to the Global Study Associate Director/Global Study Team including the SMM Lead. Contribute to patient recruitment strategy and maintain communication with participating Investigators as necessary. Develop and review risk management plans at country study level; manage sites, stakeholders, vendors and customers to identify, mitigate, and manage risks. Coordinate with National Co-ordinating Investigator / National Lead Investigator on recruitment and study matters as applicable. Plan and lead National Investigator meetings in line with local codes as required. Assist in forecasting study timelines, resources, recruitment, budget, study materials, and drug supplies. Ensure systems to support business-critical activities (e.g., Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set up, updated, and accessible at the country level. Ensure accurate payments related to the study are performed according to local regulations and agreements. Participate in training and coaching of Local Study Team members to ensure compliance with ICH-GCP and Procedural Documents. Ensure completeness of the eTMF and timely upload of essential documents to maintain an Inspection Ready eTMF; prepare for final archiving and completion of the local eTMF. Plan and lead activities related to audits and regulatory inspections in liaison with CQAD and QA. Provide input to process development and improvement; keep Line Managers informed on study milestones and issues; update on CRA/CSA performance. Ensure study activities at country level comply with local policies and code of ethics; provide feedback on research information relevant to the local market. Ensure compliance with company Code of Ethics, policies and procedures related to people, finance, technology, security and SHE. Collaborate with the local Medical Affairs team. Your Profile Bachelor degree in a related discipline (life sciences preferred) or equivalent qualification. Minimum 5 years of clinical trial experience with at least 1 year of single-country trial management experience. Strong knowledge of ICH-GCP guidelines and local regulations. Excellent project management, organizational and interpersonal skills. Strong verbal and written communication abilities and the ability to prioritize and manage multiple tasks. Proficiency in English (spoken and written); good negotiation skills; ability to adapt to IT systems. Location: Canada - East What ICON Can Offer You ICON offers a competitive salary and a range of benefits designed to support well-being and work-life balance. Benefits are tailored to each country. Various annual leave entitlements Health insurance offerings for you and your family Competitive retirement planning offerings Global Employee Assistance Programme (LifeWorks) Life assurance Flexible country-specific optional benefits ICON is committed to inclusion and belonging and to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you require a reasonable accommodation during the application process, please contact us. If you’re unsure whether you meet all requirements, we encourage you to apply—there’s a chance you are exactly what ICON is looking for. If you are a current ICON employee, please apply here. #J-18808-Ljbffr