Associate Director, Clinical Trial Management - Canada

Résumé du poste

The Associate Director manages day-to-day clinical trial operations, ensuring compliance with ICH/GCP regulations and study protocols. They serve as the primary sponsor contact, oversee cross-functional project teams, and manage study deliverables, risk assessments, and vendor relationships.

Détails du poste

Medpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers / Clinical Project Directors to join our team in Canada. Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular, Renal, Gastrointestinal, Endocrine/Metabolic, Immunology, Inflammation, Infectious Disease, Neuroscience, Ophthalmology and more. This is a home-based position in Canada. Responsibilities Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations Serve as primary Sponsor contact for operational project-specific issues and study deliverables Maintain in depth knowledge of protocol, therapeutic area, and indication Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable Develop operational project plans Manage risk assessment and execution Manage study vendors where applicable Manage site quality and monitoring deliverables Qualifications Bachelor’s degree in a health-related field required; Advanced degree in a health-related field preferred Experience in Phases 1-4; Phases 2-3 preferred 5+ years as a project/clinical trial manager within a CRO required; Management of overall project timeline; Bid defense experience; Strong leadership skills Medpace Overview Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries. Why Medpace? When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration. Purpose-Driven Work Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence Collaborative Culture Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust. Leadership throughout Medpace is both accessible and approachable Continuous Growth & Development Office based environment with on-site mentors Defined career paths with clear advancement opportunities Industry renowned onboarding and training programs designed to accelerate professional development Ongoing training and continuous learning opportunities throughout your career An environment that encourages employees to influence change, contribute ideas, and grow quickly Other Employee Benefits Competitive compensation programs that recognize and reward performance Comprehensive health, wellness, retirement, and PTO benefits Office based culture with occasional WFH that provides flexibility for eligible positions after training Company-sponsored social events Please note benefits may vary based on country. What to Expect Next A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.

Ce que vous ferez

The Associate Director manages day-to-day clinical trial operations, ensuring compliance with ICH/GCP regulations and study protocols. They serve as the primary sponsor contact, oversee cross-functional project teams, and manage study deliverables, risk assessments, and vendor relationships.

Exigences

Candidates must hold a bachelor's degree in a health-related field and possess at least 5 years of experience as a project or clinical trial manager within a CRO. Strong leadership skills, experience with Phases 1-4 clinical trials, and bid defense experience are required.

Avantages

• Health insurance • Wellness programs • Retirement benefits • Paid time off

Compétences indiquées

• Gestion de projet · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical trial management
• Project management
• Oncology
• Hematology
• ICH/GCP compliance
• Risk assessment
• Vendor management
• Protocol development
• Cross-functional leadership
• Bid defense
• Clinical research
• Regulatory compliance
• Data analysis plan review
• Study report preparation
• Influencing Skills
• Cross-Functional Collaboration
• Continuous Development
• Influencing Without Authority
• Accountability
• Medical Devices
• Research
• Data Analysis
• Biotechnology
• Management
• Cardiology
• Metabolism
• Decision Making
• Pre-Clinical Development
• Immunology
• Clinical Research
• Clinical Trials
• Communication
• Training And Development
• Creative Thinking
• Endocrinology
• Gastroenterology
• Leadership
• Good Clinical Practices (GCP)
• Innovation
• Infectious Diseases
• Neuroscience
• Neurology
• Ophthalmology
• Employee Onboarding
• Operations
• Pharmaceuticals
• Risk Analysis

Domaines d’emploi

• Healthcare
• Management & Leadership
• Science & Research
• Associate Clinical Director
• Clinical Director
• Health Service Managers
• Medical and Health Services Managers