Global Study Start-Up Lead

Ergomed; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Ergomed Group seeks a Study Start Up Specialist to coordinate site activations in line with contracts, trial protocol and ICH-GCP/regulatory requirements. You will lead start-up strategy, drive regulatory deliverables, and act as the primary contact for sponsor and internal teams to ensure timely activation of study sites.

You will review regulatory information, support submissions, manage essential documents, and help mitigate risks while mentoring junior staff and collaborating across

Qualifications

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
• Minimum 5 years in pharmaceutical/CRO industry.
• Experience managing multi-country start-up projects.

Responsibilities

• Lead study start-up strategy and regulatory deliverables.
• Serve as main contact for all project start-up activities.
• Provide regulatory strategic input and manage risk.
• Prepare and review regulatory submissions for initial authorization and maintenance.
• Coordinate with sites for document collection and ICF/IRB submissions.
• Negotiate contracts with investigative sites per project RACI.
• Assist with feasibility and site identification activities.
• Ensure TMF filing and training and attendance at project meetings.

Skills

Regulatory Coordination

Project Leadership

ICH-GCP Knowledge

Multi-country Management

Documentation Control

Education

Bachelor's in Chemistry or Life Sciences

Tools

MS Office

Job description

Ergomed Group seeks a Study Start Up Specialist to coordinate site activations in line with contracts, trial protocol and ICH-GCP/regulatory requirements. You will lead start-up strategy, drive regulatory deliverables, and act as the primary contact for sponsor and internal teams to ensure timely activation of study sites.

You will review regulatory information, support submissions, manage essential documents, and help mitigate risks while mentoring junior staff and collaborating across