Study Start-up Manager

Study Start-Up Hub – Study Start-up Manager

Let’s do this. Let’s change the world. In this vital role you will drive the planning and execution of clinical study start-up activities, ensuring trials are launched efficiently, compliantly, and to the highest quality standards.

• Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met.
• Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track.
• Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration.
• Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start.
• Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed.
• Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution.
• Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities.
• Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub.

Basic Qualifications

• Pharma Expertise: Requires pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required.
• Management Experience: Requires experience leading and managing global teams and project management experience.
• Tech Skills: No prior Veeva experience required.
• Doctorate degree OR Master’s degree and 3 years of clinical execution experience OR Bachelor’s degree and 5 years of clinical execution experience OR Associate’s degree and 10 years of clinical execution experience OR High school diploma / GED and 12 years of clinical execution experience.
• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Preferred Qualifications

• 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company.
• Experience working in global clinical trial teams across multiple geographies.
• Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management.
• PMP Certification.