Clinical Compliance Consultant - Remote

Overview

The Clinical Compliance Consultant is responsible for supporting GCP Compliance infrastructure build and maintenance, including Clinical SOP development, storyboard development for inspection readiness, and acting as a Compliance SME for the clinical study teams.

In Short

• Part-time position, expected 10-20 hours/week.
• Lead development and implementation of GCP Excellence in Clinical Trials strategies.
• Collaborate with study execution teams on adherence to clinical trial delivery procedures.
• Proactively identify and assess process and project risks.
• Identify and implement areas for process optimization.
• Partner with Quality Assurance for compliance oversight.
• Serve as subject matter expert for Inspection Readiness and TMF.
• Contribute to GCP Excellence initiatives and departmental goals.
• Requires collaboration with internal and external stakeholders.
• Minimum monthly or quarterly travel to Boston, MA required.

Requirements

• Bachelor’s or Master’s degree in life sciences with 10+ years of clinical drug development experience.
• Expertise in global clinical trial execution and knowledge of key clinical systems (CTMS, IRT, eTMF, EDC).
• Strong understanding of ICH-GCP guidelines and vendor management.
• Experience in leading projects and coordinating collaboration.
• Strong strategic thinking and communication skills.
• Global/international experience required.
• Excellent leadership and organizational skills.

Benefits

• Competitive health, dental, and vision coverage.
• Life insurance and disability insurance.
• Discretionary time off and paternity leave.
• Excellent 401(k) package.
• Transportation stipend.