Associate Clinical Trial Management Director – ACTMD

• Lead and work alongside clinical teams to improve clinical trial delivery and accelerate bringing new drugs to market
• Serve as a member of the core project team responsible for delivery of full-service, large, multi-regional studies or programs of studies
• Ensure clinical delivery complies with regulatory, customer and internal requirements
• Meet project recruitment targets and implement appropriate recruitment strategies
• Develop risk mitigation plans and manage clinical risks throughout the project lifecycle
• Set and develop clinical strategies to achieve project goals
• Ensure clinical quality delivery by identifying standards, measuring compliance, and managing clinical quality issues
• Manage clinical aspects of project finances, including Estimate at Completion (EAC), scope, plans, changes and out-of-scope work
• Work as the primary Clinical Lead alongside other Clinical Leads on large, global trials
• Manage internal and external stakeholders and resolve issues
• Collaborate with clinical teams to support milestones and report to stakeholders
• Plan resources and talent for the clinical team and manage project-level operational plans, guidance and training
• Conduct team meetings and communicate to achieve objectives
• Support professional development by providing performance feedback to clinical team line managers
• Contribute to clinical delivery strategies for business proposals and participate in bid defense preparations and meetings
• Develop and present Clinical Operation Plans with Business Development and Project Leadership
• Mentor and coach peers entering clinical lead roles
• Act as a departmental cross-functional liaison or change agent as needed
• Attend site visits as applicable and participate in function, corporate or special project initiatives

• Bachelor's Degree in Health care or another scientific discipline
• 10 years of clinical research/monitoring experience or equivalent combination of education, training and experience
• In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Consolidated knowledge of Project Management practices and terminology
• High proficiency in using systems and technology to achieve work objectives
• Good knowledge of project finances
• Knowledge of clinical trial conduct and applicable clinical research regulatory requirements, including ICH, GCP, and relevant local laws, regulations and guidelines
• Strong written and verbal communication skills, including good command of English
• Problem-solving skills
• Planning, time management and prioritization skills
• Ability to handle conflicting priorities
• Attention to detail and accuracy
• Results-oriented approach to work delivery and output
• Good influencing and negotiation skills
• Good judgment and decision-making skills
• Effective mentoring and training skills
• Microsoft Office applications, including Microsoft Word, Excel and Power Point
• Ability to establish and maintain effective working relationships
• Ability to work across geographies with awareness and understanding of cultural differences
• Ability to demonstrate IQVIA
  
  Core Competencies:
  
  Client Focus, Collaboration, Communication, Innovation and Ownership

Demonstrates extensive experience in clinical trial management, ensuring compliance with GCP and ICH guidelines while effectively leading cross-functional teams. Proficient in project finance management and skilled in developing strategies to meet recruitment targets and enhance clinical delivery.

• Clinical Trial Management
• Good Clinical Practice (GCP)
• Project Management
• Stakeholder Management
• Risk Mitigation

• Clinical Research
• Project Finance Management
• Regulatory Compliance
• Clinical Quality Assurance
• Recruitment Strategy Development
• Risk Management
• Clinical Operation Planning
• Performance Feedback
• Microsoft Office Applications
• Time Management

• Communication Skills
• Problem-Solving Skills
• Attention to Detail
• Negotiation Skills
• Mentoring Skills

• International Conference on Harmonization (ICH)
• Clinical Trial Conduct
• Health Care
• Scientific Discipline
• Client Focus
• Collaboration
• Innovation
• Ownership