Remote Senior Site Activation Lead — Start-Up & Compliance

Worldwide Clinical Trials; Olympia (WA); Remote; USD 107.000 - 213.000; Vollzeit

Zusammenfassung

Worldwide Clinical Trials is seeking a Senior Site Activation Manager II for a remote US-based role. You will lead start-up and site activation efforts across complex studies and collaborate with sponsors, regulators, and sites to maintain quality and timelines.

You will mentor peers, drive process improvements, and ensure compliance with ICH GCP and regulatory standards while managing budgets and cross-functional teams.

Qualifikationen

• Bachelor's degree in a related field or equivalent clinical research experience.
• Minimum 7 years of CRO or pharmaceutical industry experience, in start-up/project/site management or related functions.
• Strong leadership and project management, planning, organizational and decision-making skills.
• Knowledge of ICH GCP guidelines and FDA/EU clinical trial regulations.

Aufgaben

• Lead and oversee study start-up and site activation activities across assigned clinical research projects.
• Serve as the primary point of contact for site activation deliverables, timelines, and project performance.
• Coordinate cross-functional teams to ensure critical path activities are completed on time and within budget.
• Monitor site identification, qualification, essential document collection, regulatory submissions, and contract progression.
• Assess project risks, develop mitigation strategies, and escalate issues to support on-time delivery.
• Track, analyze, and communicate site activation metrics, milestones, and project status to sponsors and internal stakeholders.
• Develop and maintain site activation plans with project teams and ensure budgets reflect study requirements.
• Contribute to proposals, budgets, bid defenses, and other business development activities related to site activation.
• Coach and mentor Site Activation Managers and support SOPs and best practices.

Kenntnisse

Leadership

Project management

Cross-functional collaboration

Stakeholder communication

Ausbildung

Bachelor's degree

Two-year degree + 4 years experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Digital systems

Jobbeschreibung

Worldwide Clinical Trials is seeking a Senior Site Activation Manager II for a remote US-based role. You will lead start-up and site activation efforts across complex studies and collaborate with sponsors, regulators, and sites to maintain quality and timelines.

You will mentor peers, drive process improvements, and ensure compliance with ICH GCP and regulatory standards while managing budgets and cross-functional teams.