Global Study Start-Up Associate II

The Emmes Company, LLC; Rockville (MD); On-site; USD 60,000 - 85,000; Full time

Job summary

The Emmes Company, LLC is seeking a Study Start-Up Associate II to join the centralized Site and Patient Access group in Rockville, MD. You will support regulatory submissions, track essential documents, and coordinate with cross-functional teams to ensure timely startup of international trials.

Responsibilities include creating timelines, preparing submission packages, and maintaining trackers while liaising with sponsors and regulatory authorities as required.

Qualifications

• Bachelor's degree in healthcare-related field required.
• Master's degree healthcare-related field preferred.
• 1–3 years pharma/CRO study start-up experience recommended.

Responsibilities

• Create MS Project files to establish study start-up timelines per country.
• Prepare regulatory submission packages and liaise with regulatory authorities.
• Track missing documents and maintain trackers and templates.
• Coordinate translations and assist in regulatory coordination as needed.
• Support senior staff and study leads in site activation activities.

Skills

Communication

Organizational skills

Prioritization

Independence

Microsoft Office

Education

Bachelor's degree in healthcare-related field

Master's degree healthcare-related field

Tools

MS Project

Word

Excel

Job description

The Emmes Company, LLC is seeking a Study Start-Up Associate II to join the centralized Site and Patient Access group in Rockville, MD. You will support regulatory submissions, track essential documents, and coordinate with cross-functional teams to ensure timely startup of international trials.

Responsibilities include creating timelines, preparing submission packages, and maintaining trackers while liaising with sponsors and regulatory authorities as required.