Remote Senior Study Start-Up Lead

Ergomed; Raleigh (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We seek a Study Start Up Specialist to coordinate and oversee site activations, lead start-up strategy, and manage regulatory deliverables in a fast-paced, international environment.

Minimum 5 years in pharma/CRO, strong organizational and communication skills, and proficiency in MS-Office are required.

Qualifications

• Bachelor's degree in Chemistry or Life Sciences, Nursing or equivalent experience.
• Minimum 5 years within pharmaceutical/CRO industry.
• Experience managing multi-country start-up projects.
• Excellent organizational and management skills.

Responsibilities

• Lead study start-up activities and coordinate regulatory deliverables.
• Serve as main contact for project start-up activities.
• Support regulatory submissions and TMF documentation.
• Coordinate with sites, sponsors and internal teams.

Skills

Organizational skills

Project coordination

Regulatory knowledge

Communication

Education

Bachelor's degree in Chemistry or Life Sciences

Tools

MS-Office

Job description

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We seek a Study Start Up Specialist to coordinate and oversee site activations, lead start-up strategy, and manage regulatory deliverables in a fast-paced, international environment.

Minimum 5 years in pharma/CRO, strong organizational and communication skills, and proficiency in MS-Office are required.