Global Study Associate Director

This is a fully remote position, open to applicants in United States, +3 more locations.

📋 Description

• Lead, guide, and effectively delegate tasks to a cross-functional study team or supervise outsourced delivery activities.

• Ensure that clinical studies progress as intended, meeting milestones in accordance with timelines, budget, and quality standards.

• Facilitate effective communication across various functions, external partners, and service providers.

• Organize and conduct investigator meetings and other meetings related to the study.

• Contribute to and take responsibility for essential study-level documents, from the Clinical Study Protocol to the Clinical Study Report.

• Develop and sustain study plans, quality and risk management plans, risk response strategies, and issue escalation procedures.

• Supervise external service providers, including CROs, central laboratories, IXRS, and ePRO vendors.

• Identify and report quality issues within the study and communicate corrective action plans effectively.

• Ensure the completion of the Trial Master File and ongoing quality-control activities.

• Maintain compliance with governance controls, including Delegation of Authority, Sunshine Act, financial attestations, and Clinical Trial Transparency.

• Reforecast and manage study budgets, providing budget progress reports and mitigation strategies.

• Ensure that studies remain inspection-ready in accordance with ICH-GCP, SOPs, and relevant policies, acting as the primary Study Management contact during audits or inspections.

• Provide performance feedback and mentor less experienced team members.

⛳️ Requirements

• A university degree (or equivalent), ideally in medical or biological sciences or a field related to clinical research.

• A minimum of 5 years of relevant clinical experience in the pharmaceutical industry, specializing in Clinical Project/Trial Management.

• Proven experience in overseeing large-scale global clinical trial projects.

• Experience in managing Oncology studies/projects is essential.

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.