Associate Director, Clinical Trial Start-Up

Jobtailor; Deutschland; Remote; EUR 100.000 - 150.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks an experienced Senior SSU lead to drive global site start-up strategies, activation plans, and risk mitigation. You will partner with cross-functional teams to optimize timelines, oversee CRO/vendors, and ensure regulatory submissions readiness.

The role requires 8–10 years in clinical research, with 5+ years focused on trial start-up or site activation, and strong data-driven decision-making.

Qualifikationen

• Recognized as a subject matter expert in clinical site start-up with strong regulatory understanding (IRB/EC) and site activation pathways.
• Proven ability to drive cross-functional decision-making through data-driven insights and timelines.
• Experience leading global clinical start-up strategy with in-house or outsourced models, overseeing CROs/vendors.
• Experience leveraging digital technologies to inform study planning and start-up optimization.
• Able to analyze complex issues and apply strategic thinking to mitigate risk and resolve operational challenges.
• Strong leadership, collaboration, and communication skills to influence cross-functional teams and external partners.

Aufgaben

• Lead or oversee development and execution of study start-up strategies, country/site activation plans, and risk mitigation.
• Develop activation projections and input study timelines via data-driven assessment of country requirements and historical timelines.
• Serve as SME in global study start-up pathways and regulatory submissions readiness.
• Collaborate across functions to deliver start-up insights for country/site selection, timelines, and activation strategies.
• Track SSU performance metrics, identify trends, and address risks with clear communication.
• Oversee CROs/vendors performing start-up activities and monitor KPIs and timelines.
• Lead initiatives to improve start-up methodology, tools, and process efficiency.

Kenntnisse

Clinical SSU

Cross-Functional Leadership

CTMS Proficiency

Veeva Vault

Data Analysis

AI Utilization

Regulatory Compliance

Leadership

Communication

Site Activation

Ausbildung

Bachelor’s degree in life sciences

Tools

CTMS

Document Management Systems

SSU Technology Platforms

Veeva Vault

Jobbeschreibung

• Lead or provide oversight of development and execution of study-level start-up strategies, country/site activation plans, and risk mitigation approaches through SSU roles and/or CRO
• Develop site activation projections and provide input into study timeline development through data-driven assessment of country requirements, historical timelines, predictive data, and emerging technologies
• Serve as a Subject Matter Expert in global study, country, and site start-up pathways
• Partner cross-functionally to deliver start-up insights and strategies informing country and site selection, timelines, and activation strategies
• Track and analyze SSU performance metrics, identify trends and issues, and address and communicate risks
• Leverage historical and predictive data, real-world evidence, and emerging technologies to optimize start-up strategies and activation processes
• Oversee SSU team members, providing guidance, training, and performance feedback
• Oversee CROs/vendors executing start-up activities, including performance tracking against KPIs and timelines
• Lead or contribute to initiatives improving start-up methodology, quality, tools, and process efficiency
• Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions
• Participate in development and refinement of global SSU policies, SOPs, and training curricula
• Represent SSU in industry discussions, cross-industry collaboration efforts, and internal governance meetings

Requirements

• Recognized as a subject matter expert in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways
• Proven ability to drive cross-functional decision-making through data-driven insights
• Demonstrated success supporting or leading global clinical start-up strategy in both in-house and outsourced models, specifically oversight of CROs or vendors
• Experience leveraging digital technologies to inform study planning and start-up optimization
• Ability to analyze complex issues and apply strategic thinking to identify risk and resolve operational challenges across cross-functional settings
• Strong leadership, collaboration, and communication skills, with the ability to influence cross-functional teams and external partners
• Proficiency with CTMS, document management systems, and SSU technology platforms (e.g., Veeva Vault)
• Experience in assessment or utilization of AI in this SSU space preferred
• Experience contributing to inspection readiness and continuous process improvement initiatives
• 10% to 20% travel, US and International
• Bachelor’s degree in life sciences or related field required
• 8-10 years of experience in clinical research, with at least 5 years focused on clinical trial start up or site activation

Core Competencies

Demonstrates expertise in clinical site start-up strategies, regulatory requirements, and cross-functional collaboration to optimize study timelines and activation processes. Proven ability to lead teams, analyze performance metrics, and implement continuous improvement initiatives in clinical research.

Highest-signal resume keywords

• Clinical Site Start-Up Expertise
• Cross-Functional Decision-Making
• CTMS Proficiency
• Leadership in Clinical Research
• Data-Driven Insights

ATS Optimization Keywords

Hard Skills

• Clinical Trial Start-Up
• Site Activation Pathways
• Risk Mitigation Strategies
• Data Analysis
• Predictive Data Utilization
• Regulatory Compliance
• Performance Metrics Tracking
• Continuous Process Improvement
• Operational Strategy Development
• AI Utilization in SSU

Soft Skills

• Leadership
• Collaboration
• Communication
• Influencing Skills
• Strategic Thinking

Industry Keywords

• Global Regulatory Requirements
• IRB/EC Processes
• CRO Oversight
• Study Planning
• Inspection Readiness

Tools & Technologies

• CTMS
• Document Management Systems
• SSU Technology Platforms
• Veeva Vault