Country Study Start-Up Specialist — Clinical Trials

Planet Pharma; North Chicago (IL); On-site; USD 72,000 - 85,000; Full time

Job summary

Planet Pharma in the United States is seeking a Specialist, Country SSU to drive start-up and maintenance activities for assigned studies and sites. You will collect essential documents, coordinate regulatory submissions, ensure ALCOA data quality, and track start-up KPIs while collaborating with cross-functional teams to meet activation timelines.

You will train and mentor junior Specialists, maintain Vault SSU data, and ensure compliance with ICH/GCP guidelines across the country.

Qualifications

• Minimum 3–5 years of clinical research experience; 1+ years in start-up management preferred.
• Experience working with remote/virtual teams and cross-functional partners.
• Solid understanding of ICH and GCP guidelines and regulatory environments.

Responsibilities

• Ensure on-time, high-quality start-up and maintenance activities for sites and studies.
• Collect essential documents and perform ALCOA quality checks.
• Coordinate regulatory submissions and ICF customization; track activation status and KPIs.

Skills

Clinical start-up management

Remote/virtual teamwork

Documents & ALCOA quality

Regulatory compliance

Stakeholder communication

Education

Bachelor’s Degree in health care or scientific field

Tools

IXRS system

Vault SSU

Job description

Planet Pharma in the United States is seeking a Specialist, Country SSU to drive start-up and maintenance activities for assigned studies and sites. You will collect essential documents, coordinate regulatory submissions, ensure ALCOA data quality, and track start-up KPIs while collaborating with cross-functional teams to meet activation timelines.

You will train and mentor junior Specialists, maintain Vault SSU data, and ensure compliance with ICH/GCP guidelines across the country.