Clinical Trial Operations & TMF Specialist

Scorpion Therapeutics; New York (NY); On-site; USD 90,000 - 140,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced Clinical Operations Specialist to manage TMF for multiple trials and ensure inspection readiness. You will partner across functions, develop tracking tools, and support CRO oversight and trial communications.

Responsibilities include reviewing site visit reports, maintaining TMF metrics, and assisting with investigator site payments and site feasibility activities.

Qualifications

• 2+ years’ experience in Veeva Vault.
• 2+ years’ experience in clinical operations (CRO and Sponsor experience desired).
• Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
• Demonstrated ability partnering with CROs and vendors.
• Proficiency with Veeva TMF, Word, Excel, PowerPoint and SmartSheet.
• Proactive and efficient in fast-paced environments.
• Excellent written and oral communication; strong organization.
• Bachelor’s degree in science or healthcare is preferred.

Responsibilities

• Maintain Trial Master Files (TMF) for assigned clinical trials per SOPs and ensure inspection readiness.
• Provide TMF metrics to internal/external stakeholders.
• Partner cross-functionally to follow the trial master oversight plan.
• Develop/maintain tracking tools for patient recruitment, site ramp-up and monitoring visits.
• Assist CRO oversight and participate in Clinical Trial Working Groups.
• Review monitoring visit reports and site-specific Informed Consent Forms.
• Track site feasibility questionnaires and assist with investigator site payments.

Skills

Veeva Vault

Clinical operations

FDA & ICH-GCP knowledge

Vendor/CRO management

Strong communication

MS Office Suite

SmartSheet

Education

Bachelor's degree in science/healthcare

Tools

Veeva TMF

Word

Excel

PowerPoint

SmartSheet

Job description

Scorpion Therapeutics seeks an experienced Clinical Operations Specialist to manage TMF for multiple trials and ensure inspection readiness. You will partner across functions, develop tracking tools, and support CRO oversight and trial communications.

Responsibilities include reviewing site visit reports, maintaining TMF metrics, and assisting with investigator site payments and site feasibility activities.