Associate Site Activation Director

IQVIA•Durham, NC
•$91,300 - $270,700

About The Position

The Associate Site Activation Director leads the strategic, operational, and financial delivery of site activation activities across assigned clinical programs, regions, and customer engagements. The role oversees site identification and selection, regulatory and ethics approvals, site contracting, and activation, ensuring studies begin efficiently, compliantly, and in alignment with customer expectations. As a senior subject matter expert and strategic partner to sponsors, project leadership, and Site Activation teams, the director drives operational excellence, customer satisfaction, and continuous improvement across the clinical trial startup lifecycle. The position supports faster study startup, enrollment readiness, and successful delivery of complex global clinical programs. The role provides strategic leadership for global and regional startup activities, develops and oversees activation plans, guides regulatory strategy and risk management, and monitors operational and financial performance. It partners with customers and cross-functional teams, supports business development and proposals, mentors startup professionals, and leads initiatives to improve processes, quality, and customer experience.

Requirements

  • Bachelor's degree in Life Sciences, Health Sciences, Pharmacy, Nursing, or a related field, or an equivalent combination of education and experience.
  • At least 8 years of experience in clinical research, site activation, regulatory affairs, or clinical operations.
  • At least 5 years of leadership experience managing complex global or regional clinical trial startup activities.
  • Demonstrated experience leading multinational studies and working across diverse regulatory environments.
  • Experience in customer-facing roles and managing strategic stakeholder relationships.
  • Experience supporting business development activities, proposals, and bid defense presentations.
  • Ability to lead through influence in a complex global matrix organization.
  • Strong strategic thinking and decision-making skills, including balancing operational execution with long-term business objectives.
  • Ability to exercise sound judgment, take calculated risks, and resolve highly complex issues.
  • Advanced understanding of the global clinical trial environment and drug development process.
  • Expert knowledge of ICH-GCP, global regulatory requirements, ethics review processes, and site activation methodologies.
  • Strong regulatory intelligence skills and ability to translate regulatory changes into actionable startup strategies.
  • Excellent customer relationship management skills and ability to build trusted partnerships.
  • Strong financial acumen, including experience managing budgets, forecasts, scope changes, and operational performance metrics.
  • Ability to influence customers, sponsors, and senior stakeholders to achieve desired outcomes.
  • Exceptional communication, negotiation, presentation, and stakeholder management skills.
  • Ability to lead cross-functional teams and drive results through collaboration and influence.
  • Ability to communicate effectively with operational teams, executive leadership, and external customers.
  • Demonstrated success managing multiple complex projects with competing priorities.
  • Strong analytical and problem-solving skills and a proactive approach to risk identification and mitigation.
  • Proficiency with clinical systems, project management tools, reporting platforms, and startup technologies.
  • Track record of driving process improvements, operational efficiencies, and measurable business results.

Responsibilities

  • Lead planning, execution, and oversight of global and regional site activation activities against timeline, quality, budget, and customer expectations.
  • Develop site activation strategies from pre-award through activation and lifecycle maintenance, identifying ways to accelerate startup and reduce activation timelines.
  • Oversee study startup delivery across assigned regions and countries, ensuring alignment with scope, customer requirements, and operational objectives.
  • Serve as a senior escalation point for complex startup challenges and drive issue resolution.
  • Partner with global study teams to identify risks, assess impacts, and implement mitigation plans.
  • Develop, implement, and oversee Site Activation Management Plans aligned with project strategy, Scope of Work, and contractual commitments.
  • Ensure startup activities comply with ICH-GCP, applicable regulatory requirements, study protocols, sponsor expectations, and company quality standards.
  • Oversee study approvals, regulatory submissions, ethics review, contract negotiations, and essential document management.
  • Monitor project performance using metrics, timelines, KPIs, and financial measures.
  • Ensure accurate maintenance of startup systems, databases, forecasting tools, project plans, and reporting platforms.
  • Provide strategic guidance on regulatory pathways, submission requirements, ethics approvals, and country-specific startup requirements.
  • Evaluate regulatory changes and use regulatory intelligence to optimize startup strategy and execution.
  • Identify regulatory complexities and operational barriers, and develop practical solutions that support business development and study delivery.
  • Lead risk assessment and mitigation, identifying critical-path challenges and implementing resolution strategies.
  • Manage site activation budgets, forecasts, and resource utilization across assigned studies and programs.
  • Partner with Project Management, Finance, and Operational Leadership to meet contractual commitments and financial targets.
  • Support proposal development, competitive bids, and bid defense activities with strategic startup expertise and operational insight.
  • Evaluate performance and implement efficiencies that improve productivity, customer satisfaction, and financial outcomes.
  • Build and maintain sponsor and strategic customer relationships, serving as a senior advisor on startup strategy and execution.
  • Lead customer-facing workstreams and partnership initiatives to improve startup performance, operational effectiveness, and service delivery.
  • Represent Global Site Activation in governance meetings, partnership reviews, and early engagement discussions.
  • Deliver executive-level status updates, operational insights, and risk assessments to customers and internal leadership.
  • Mentor, coach, and support the development of Site Activation Managers and other startup professionals.
  • Foster accountability, collaboration, innovation, and continuous improvement across the Global Site Activation organization.
  • Support talent development, succession planning, and onboarding of new team members.
  • Share subject matter expertise through presentations, training programs, industry forums, and professional organizations.
  • Lead departmental and cross-functional initiatives that enhance startup processes, quality outcomes, and customer experience.
  • Promote innovation and best practices, using technology and data-driven insights to improve performance.
  • Contribute to operational standards, governance models, and process improvements.
  • Provide expertise and recommendations on startup operations, regulatory trends, and industry practices to inform organizational strategy.

Benefits

  • Health and welfare benefits may be offered, depending on the position.
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