Global Study Start-Up Lead (Remote)

Initial Therapeutics, Inc.; United States; On-site; USD 122,229 - 150,449; Full time

Benefits offered by this job

Comprehensive benefits

Bonus program

Stock-based incentives

Flexible work models

Job summary

Amgen is hiring a Study Start Up Hub Study Start‑up Manager to drive the planning and execution of clinical study start‑up activities, ensuring trials launch efficiently, compliantly, and to the highest quality standards.

You will lead global-to-local start‑up planning, own milestones, collaborate with cross‑functional teams, assess risks, and apply ICH‑GCP expertise to deliver high‑quality execution, with strong resource and supplier management.

Qualifications

• Pharma and clinical trial processes and operations expertise required.
• Experience leading and managing global teams and project management experience required.
• No prior Veeva experience required (as noted).
• Multiple education paths satisfying the minimum clinical execution requirements.

Responsibilities

• Lead planning and delivery of global-to-local study start-up activities, 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 updates, solutions, and escalation where needed.
• Apply strong regulatory knowledge (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.

Skills

Pharma Expertise

Management Experience

Tech Skills

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

Veeva

Job description

Amgen is hiring a Study Start Up Hub Study Start‑up Manager to drive the planning and execution of clinical study start‑up activities, ensuring trials launch efficiently, compliantly, and to the highest quality standards.

You will lead global-to-local start‑up planning, own milestones, collaborate with cross‑functional teams, assess risks, and apply ICH‑GCP expertise to deliver high‑quality execution, with strong resource and supplier management.