Clinical Trial Manager / Sr. Manager

Scorpion Therapeutics; South San Francisco (CA); Hybrid; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical Trial Manager/Senior Manager to oversee global clinical trial operations from start-up through close-out, ensuring milestones, quality, and regulatory compliance.

You will manage trial activities, develop study protocols, oversee CRO/vendor performance, mitigate risks, support TMF quality and SOPs, and collaborate with Biometrics, Quality, Regulatory, and CMC in a hybrid setup based in South San Francisco, with onsite Mondays and Tuesdays.

Qualifications

• Bachelor's degree required; 8+ years in Clinical Operations/Development/PM.
• Experience in managing oncology early-phase trials, solid tumors.
• Global trial oversight, vendor management, regulatory inspections.
• Strong knowledge of ICH/GCP, EDC, IRT, CTMS, eTMF systems.

Responsibilities

• Oversee global clinical trial operations from start-up through close-out.
• Develop study protocols and materials.
• Oversee CRO/vendor performance and risk mitigation.
• Support TMF quality and SOP development; collaborate with cross-functional teams.

Skills

Global trial oversight

Vendor management

Regulatory inspections

ICH/GCP knowledge

GCP/CTMS/eTMF systems

Education

Bachelor's degree in a relevant field

Tools

EDC

IRT

CTMS

eTMF

Job description

Role

Clinical Trial Manager/Senior Manager responsible for overseeing global clinical trial operations from start-up through close-out, ensuring milestones, quality, and compliance are met.

Responsibilities

Managing trial activities, developing study protocols and materials, overseeing CRO/vendor performance, risk mitigation, site selection, enrollment, and regulatory compliance; supporting TMF quality and SOP development; collaborating with cross-functional teams such as Biometrics, Quality, Regulatory, and CMC.

Requirements

Bachelor's degree plus 8+ years in Clinical Operations, Clinical Development, or Project Management; experienced in managing oncology early-phase trials, especially solid tumors; proficient in global trial oversight, vendor management, and regulatory inspections; strong knowledge of ICH/GCP, EDC, IRT, CTMS, eTMF systems; excellent problem-solving, communication, and collaboration skills.

Preferred

biotech/startup experience; RN or CRC background advantageous.

High-Value

Oncology, early-phase, solid tumor indications, global trial management, vendor oversight, GCP compliance.

Work Setup

Hybrid in South San Francisco, CA, with preference for onsite presence on Mondays and Tuesdays.