Study Start-up Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Study Start-up Manager based in United States.

The Study Start-up Manager will play a critical role in accelerating the launch of clinical studies by leading global start-up activities from planning through execution. This position ensures clinical trials begin efficiently, compliantly, and according to quality, regulatory, and operational standards. You will collaborate with cross-functional teams, local study teams, and external partners to drive successful study activation. The role combines project leadership, regulatory expertise, risk management, and process improvement within a global clinical research environment. You will help optimize start-up strategies, resolve operational challenges, and support the delivery of innovative therapies to patients. The ideal candidate is a proactive leader with strong clinical operations experience and the ability to manage complex global initiatives. This is an opportunity to make a meaningful impact while contributing to the advancement of clinical research programs.

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.

Coordinate 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.

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.

Strong understanding of pharmaceutical clinical trial processes and operational requirements.

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

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.

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

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

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.

Retirement 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.

Collaborative and innovative work environment focused on advancing healthcare solutions.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1