Remote Clinical Subject Matter Expert - Trials & Compliance

Pharmavise Corporation; United States; Remote; USD 140,000 - 220,000; Full time

Benefits offered by this job

Remote work

Competitive compensation

Job summary

PharmaviseConsulting Corp. is seeking an experienced clinical development leader to guide programs from discovery through regulatory submission.

You will serve as the clinical subject matter expert, shaping trial design, patient criteria, and endpoints while ensuring alignment with GCP and ICH guidelines. You will monitor ongoing studies, evaluate safety and efficacy data, and collaborate with operations, regulatory affairs, medical affairs, and biostatistics to advance multiple therapeutic

Qualifications

• MD required with board certification or specialization preferred.
• Minimum 5 years in clinical research and development in pharma/biotech/CRO/academia.
• Deep understanding of study design, execution, and regulatory requirements (GCP, ICH E6(R2)).

Responsibilities

• Serve as the primary clinical expert guiding clinical development programs.
• Interpret protocols, designs, and development plans for scientific rigor and regulatory compliance.
• Provide strategic guidance on trial design, patient criteria, endpoints, and conduct.
• Monitor trials for safety, data integrity, and protocol adherence; identify optimization opportunities.
• Analyze clinical data and safety/efficacy outcomes to support decisions and regulatory submissions.
• Collaborate with cross-functional teams to drive clinical program execution.

Skills

Clinical trial design

Regulatory compliance

GCP knowledge

Leadership

Cross-functional collaboration

Education

MD

Board certification (preferred)

Tools

SAS

Job description

PharmaviseConsulting Corp. is seeking an experienced clinical development leader to guide programs from discovery through regulatory submission.

You will serve as the clinical subject matter expert, shaping trial design, patient criteria, and endpoints while ensuring alignment with GCP and ICH guidelines. You will monitor ongoing studies, evaluate safety and efficacy data, and collaborate with operations, regulatory affairs, medical affairs, and biostatistics to advance multiple therapeutic