Job Title

The Senior Project Manager oversees and manages domestic, regional, and/or international projects.Indero''s Senior Project Manager is responsible for developing and managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders, effectively ensuring that variances from the plan are proactively and effectively mitigated and client expectations are met.Our Senior Project Manager is expected to have a working knowledge of drug development and clinical trial execution. S/he has overall responsibility for the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical trials. The Senior Project Manager acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development, and ensures progress reporting (resources, budget, and timeline).The Senior Project Manager also acts as a mentor and provides training to other project managers and actively contributes to continuous improvement efforts of the department.The Senior Project Manager may be requested to support additional tasks if deemed aligned with the objectives and department and/or company goals. These may include supporting cross-functional departments to perform certain region or country-specific local administrative and/or business activities.We are looking for someone who:Has at least 7 years of global clinical project management experience (including but not limited to APAC regions), managing all project phases from start-up to closure, including management of all functional services and vendors.Wishes to work for a mid-sized CRO that handles significant multisite trials, including global Phase III projects.Is seeking to grow their career within a growing company environment.Impact and ResponsibilitiesClient interactionsServe as the primary contact for sponsors, vendors, and internal teams throughout the study.May serve as a global project manager on multi-region projects.Manage key strategic clients and/or programs.Ensure assigned studies are audit ready at all times (training records, central files, system validation, etc.).Communicate effectively with sponsors, study team members, functional departments, and senior management.Draft operational plans, processes, and manuals as applicable.Serve as escalation point for project issues, proactively resolving conflicts.Oversee vendors to ensure coordination and delivery of services, including risk mitigation.Project planningOversee site and vendor budget tracking.Manage operational aspects of the trial, including timelines, budgets, resources, and vendors.Control the project budget, review hours and billed activities, and manage scope changes.Provide updates on trial progress to stakeholders, including site selection, vendor management, and risk mitigation.Develop and maintain project KPIs within scope of the contract.Define and manage resource needs and succession plans.Quality and risk managementLead study start-up processes, including kick-off meetings, TMF setup, site selection, and vendor setup.Manage quality control measures and escalate issues as needed.Lead client calls, internal meetings, and ensure documentation is completed and filed properly.Monitor the quality of study deliverables and address quality issues.Analyze discrepancies and implement corrective actions.Ensure training records are maintained and team members are trained.Review and approve responses to audits.Ensure timely development of study documents and proper TMF filing.Provide project status updates ensuring compliance with budgets, scope, and timelines.Project budget and timelinesManage recruitment status and initiatives to mitigate delays.Participate in investigator meetings.Collaborate with regulatory groups for submissions and documentation.Support site readiness and data management activities.Project team leadershipMentor junior project managers.Prepare and deliver presentations for new business.Contribute to strategic development and process improvements.Support quality assessments and regulatory submissions.Build relationships with site staff and stakeholders, including KOLs.Support start-up activities across departments.Requirements:B.Sc. in a related field to clinical research.Minimum 7 years industry experience, with at least 5 years in clinical trial project management with financial accountability.Experience:Leading multi-center, multinational trials with budgets over $25M USD.PMP certification is desirable.Experience in cost management, study startup, regulatory submissions, resource management, supervision, CRA, data management, or vendor management is an asset.Therapeutic experience in dermatology and/or rheumatology is an asset.Knowledge and Skills:Proficiency in Microsoft Office.Fluency in English; bilingualism is an asset.Strong leadership, problem-solving, decision-making, and strategic skills.Ability to work independently and under pressure.Knowledge of GCP, Health Canada, and FDA regulations.The work environmentAt Indero, you will work with talented colleagues in a collaborative, innovative, reliable, and responsive environment. We offer flexible schedules, home-based positions, and ongoing development opportunities.About InderoIndero is a CRO specializing in dermatology and rheumatology. Established in 2000, based in Montreal, we serve clients across North America and Europe. We are committed to providing equitable treatment and accommodations for applicants with disabilities.Note: Only applicants who can legally work in Australia will be considered. #J-18808-Ljbffr