Study Start-up Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the planning and execution of activities for clinical study start-up, ensuring trials are initiated efficiently, in compliance with regulations, and upheld to the highest quality standards.

• Lead the planning and implementation of clinical study start-up tasks from a global perspective down to local details, ensuring timelines, quality, budget, and regulatory obligations are fulfilled.

• Take ownership of study start-up plans and milestones, monitoring progress and addressing issues to maintain on-time delivery.

• Serve as the main point of contact for cross-functional start-up teams, promoting clarity in roles, accountability, and teamwork.

• Proactively identify, evaluate, and mitigate risks, contributing to risk assessments for studies and ensuring prompt initiation of studies.

• Collaborate closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalations as necessary.

• Utilize strong operational and regulatory knowledge (such as ICH-GCP, submission processes, and start-up procedures) to facilitate high-quality execution.

• Manage both internal resources and external vendors to ensure the efficient and compliant execution of start-up activities.

• Foster continuous improvement by sharing knowledge, mentoring colleagues, and developing best practices within the SSU hub.

⛳️ Requirements

• Requires expertise in pharmaceutical and clinical trial processes and operations; therapeutic knowledge is not necessary.

• Requires experience in leading and managing global teams, along with project management experience.

• No previous Veeva experience is necessary.

• Doctorate degree OR Master’s degree with 3 years of clinical execution experience OR Bachelor’s degree with 5 years of clinical execution experience OR Associate’s degree with 10 years of clinical execution experience OR High school diploma/GED with 12 years of clinical execution experience.

• Must have experience in direct management of personnel and/or leadership experience in leading teams, projects, programs, or directing resource allocation.

• 5 years of experience in life sciences or a medically related field, including 3 years of biopharmaceutical clinical research experience obtained through work on clinical trials in a biotech, pharmaceutical, or CRO company.

• Experience working with global clinical trial teams across diverse geographies.

• Experience with risk-based monitoring models, risk-based quality management, and/or clinical site management.

• PMP Certification.

🏝️ Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off policies and bi-annual company-wide shutdowns.

• Flexible work models, including remote work arrangements where feasible.