Senior Clinical Trials Lead (Remote)

Openkrill; United States; Remote; USD 145,000 - 177,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program

Hybrid work model

Job summary

You will contribute to master file maintenance, creation of regulatory documents, and investigator meetings while adhering to ICH E6(R3) standards. The role requires travel to meet study needs and to support global trials.

Qualifications

• Bachelor’s degree in a scientific or medical field.
• 4–6 years of clinical study experience in biotech or pharmaceutical sponsor organizations.
• Experience supporting global studies in a fast-paced environment.
• Vendor management experience in Clinical Operations.
• Excellent communication skills and ability to work in a remote environment.
• Working knowledge of ICH E6(R3) GCP principles.
• Proficiency with MS Office and SmartSheet.

Responsibilities

• Collaborate with Clinical Operations to support studies from planning through close-out.
• Lead regional site initiation activities, monitor performance, mitigate risks, and drive action items.
• Oversee CROs and other vendors, set expectations, and ensure deliverables.
• Review monitoring documentation and oversee monitor/site performance.
• Contribute to development and maintenance of study documents and regulatory submissions.
• Ensure the Trial Master File is complete and inspection-ready.
• Apply ICH E6(R3) GCP and risk-based quality management practices.
• Travel up to 20% as required.
• Support Investigator Meetings and cross-functional study discussions.

Skills

Vendor management

Communication

Remote collaboration

Global studies experience

Project coordination

Quality mindset

GCP knowledge

Education

Bachelor’s degree in scientific/medical field

Tools

MS Office Suite

SmartSheet

Job description

You will contribute to master file maintenance, creation of regulatory documents, and investigator meetings while adhering to ICH E6(R3) standards. The role requires travel to meet study needs and to support global trials.