Study Start-up Manager

Role Overview

We are seeking a committed Study Start-up Manager to accelerate clinical study launches through comprehensive leadership from initial planning steps to full execution. This position will play a pivotal role in guaranteeing clinical trials commence efficiently, compliantly, and according to required quality, regulatory, and operational standards at a global scale.

Primary Responsibilities

• Lead global and local clinical study start-up processes to meet deadlines, budgets, quality benchmarks, and regulatory prerequisites.
• Establish, manage, and oversee timelines, milestones, and deliverables for study start-up activities.
• Act as the main liaison for coordinating cross-functional start-up teams, ensuring alignment, accountability, and collaboration.
• Recognize potential risks, evaluate operational issues, and deploy risk mitigation tactics to facilitate successful study initiation.
• Collaborate with study delivery leaders and regional teams to provide progress updates, solutions, and escalation assistance where necessary.
• Apply expertise in clinical trial operations and regulatory compliance according to ICH-GCP standards.
• Coordinate both internal resources and external vendors to optimize the delivery of start-up tasks.
• Contribute to process improvement efforts by imparting knowledge, developing best practices, and mentoring within the start-up team.
• Champion initiatives aimed at enhancing efficiency and uniformity across clinical study launches.

Qualifications

• Doctorate degree, or Master’s degree with at least 3 years of clinical execution experience, or Bachelor’s degree with at least 5 years of relevant clinical experience, or equivalent qualifications.
• Proven leadership in managing teams or directing projects and resources.
• Solid understanding of pharmaceutical clinical trial operations and regulatory requirements.
• Experience collaborating with global clinical trial teams across diverse countries or regions.
• Preferred background in life sciences, healthcare, biotechnology, pharmaceutical industry, or Contract Research Organization (CRO) settings.
• Familiarity with clinical site management, risk-based monitoring, and quality management preferred.
• Strong project management abilities; PMP certification is a plus.
• Excellent communication skills for cross-functional and external stakeholder engagement.
• Strong analytical and problem-solving aptitude to manage multiple priorities in dynamic environments.
• Knowledgeable in regulatory submission processes, clinical compliance, and study start-up mechanisms.

Compensation and Benefits

• Annual base salary range approximately $122,229 to $150,449.
• Comprehensive healthcare benefits including medical, dental, and vision coverage.
• Retirement savings with company contributions.
• Flexibility with spending accounts.
• Eligibility for discretionary annual bonuses.
• Long-term incentive options through stock-based programs.
• Generous paid time off and company-wide holiday shutdowns.
• Opportunities for remote work arrangements where available.
• Life and disability insurance coverage.
• Support for professional growth and career development.
• Collaborative and innovative environment focused on advancing healthcare solutions.

Additional Information

This role is offered by a partner company managing all applications and follow-up steps directly. The partner uses AI-based evaluation to shortlist candidates fairly and efficiently based on core role requirements, but final hiring decisions lie with the partner. Applicants acknowledge personal data processing compliant with applicable data protection laws and the use of AI tools in recruitment support without replacing human judgment.