Biotech Clinical Trials Operations Specialist

Scorpion Therapeutics; Boston (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical Operations Associate to support trial planning, start-up, maintenance, and closeout activities in a biotech setting. The role involves developing study documents, liaising with investigators, and ensuring regulatory compliance.

You will review regulatory packets, monitor data quality, manage sample logistics, and assist with meeting coordination, IM supplies, TMF submissions with CROs, and study finance tasks. Strong ICH/GCP knowledge is required.

Qualifications

• BA/BS with at least 2 years of clinical research experience (investigator sites, CROs, or sponsors).
• Strong knowledge of ICH/GCP and FDA regulations.
• Effective communication and organizational skills.
• Experience with eTMFs preferred.

Responsibilities

• Develop study documents (protocols, ICFs, IBs).
• Liaise with investigators and site staff to foster sponsor-site relationships.
• Review regulatory packets.
• Monitor data quality.
• Manage biological sample logistics.
• Support meeting coordination.
• Track IMP supplies.
• Oversee TMF submissions with CROs.
• Assist with study finance, vendor invoicing, and process improvements.

Skills

Effective communication

Strong organizational skills

Cross-functional collaboration

Education

BA/BS in life sciences or related field

Tools

eTMF systems

Job description

Scorpion Therapeutics is seeking a Clinical Operations Associate to support trial planning, start-up, maintenance, and closeout activities in a biotech setting. The role involves developing study documents, liaising with investigators, and ensuring regulatory compliance.

You will review regulatory packets, monitor data quality, manage sample logistics, and assist with meeting coordination, IM supplies, TMF submissions with CROs, and study finance tasks. Strong ICH/GCP knowledge is required.