Study Start-up Manager

Accountabilities

The Study Start-up Manager will oversee the planning, coordination, and execution of clinical study start-up activities while ensuring compliance, quality, and timely delivery. This role requires strong project management capabilities, cross-functional collaboration, and the ability to identify and resolve operational challenges.

Lead global and local clinical study start-up activities, ensuring timelines, budgets, quality standards, and regulatory requirements are achieved.

Develop, manage, and monitor study start-up plans, milestones, and operational deliverables.

Serve as the central point of contact for cross-functional start-up teams, promoting accountability, alignment, and effective collaboration.

Identify potential risks, assess operational challenges, and implement mitigation strategies to support successful study initiation.

Partner with study delivery leaders, managers, and regional teams to provide updates, solutions, and escalation support when needed.

Apply knowledge of clinical trial operations, regulatory requirements, and ICH-GCP standards to ensure compliant execution.

Cook up internal resources and external vendors to support efficient delivery of start-up activities.

Contribute to continuous improvement initiatives by sharing expertise, developing best practices, and mentoring colleagues within the start-up organization.

Support process optimization efforts to improve efficiency and consistency across clinical study launches.

Requirements

The ideal candidate brings experience in clinical research operations, global study management, and team leadership. Success in this role requires strong organizational skills, regulatory knowledge, and the ability to manage complex projects across multiple stakeholders and regions.

A 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 clinical execution experience, or equivalent relevant experience.

Demonstrated experience managing teams, leading projects, programs, or directing resources.

A strong understanding of pharmaceutical clinical trial processes and operational requirements.

Experience working with global clinical trial teams across multiple countries or regions.

A background in life sciences, healthcare, biotechnology, pharmaceutical, or CRO environments preferred.

Experience with clinical site management, risk-based monitoring models, and risk-based quality management is preferred.

Strong project management skills, with PMP certification considered an advantage.

The ability to communicate effectively with cross-functional teams and external stakeholders.

A strong problem-solving skills with the ability to manage competing priorities in a fast-paced environment.

A knowledge of regulatory submissions, study start-up processes, and clinical compliance standards.

Benefits

Competitive annual base salary range of approximately $122,229-$150,449.

Comprehensive healthcare benefits, including medical, dental, and vision coverage.

Retail and savings plan with company contributions.

Flexible spending account options.

Discretionary annual bonus program.

Stock-based long-term incentive opportunities.

Award-winning paid time off programs and company-wide shutdown periods.

Flexible work models, including remote work arrangements where available.

Life and disability insurance coverage.

Professional growth and career development opportunities.

A collaborative and innovative work environment focused on advancing healthcare solutions.