Remote Clinical Subject Matter Expert - Trials & Compliance

Pharmavise Corporation; Poland; Remote; PLN 180,000 - 300,000; Full time

Job summary

Pharmavise Corporation is seeking a seasoned clinical expert to lead and oversight clinical development programs across therapeutic areas. This remote role offers engagement with cross-functional teams and external stakeholders to drive regulatory submissions and high-quality trial execution.

Ideal candidates have a strong background in clinical research with leadership experience, GCP/ICH knowledge, and potential regulatory certification; competitive compensation is offered.

Qualifications

• Advanced degree in medicine (MD) or equivalent; board certification or specialization in a relevant therapeutic area preferred.
• Minimum of 5 years of experience in clinical research and development within the pharmaceutical/biotech sector, CRO, or academia.

Responsibilities

• Serve as the primary clinical expert, providing guidance across clinical development programs.
• Review and interpret protocols, study designs, and development plans for scientific rigor and regulatory compliance.
• Provide input on trial design, including patient selection, endpoints, and conduct.
• Monitor ongoing trials for protocol adherence, safety, and data integrity; identify optimization opportunities.
• Analyze clinical data and provide insights for decision-making and regulatory submissions.
• Collaborate with clinical operations, regulatory affairs, medical affairs, and biostatistics to drive programs.
• Stay abreast of advances, trial methodologies, and regulatory requirements.
• Represent the organization externally at conferences and regulatory meetings.

Skills

Analytical skills

Leadership

Communication skills

Regulatory knowledge

Problem solving

Education

MD

Regulatory certification (board/CRA/CPI) preferred

Job description

Pharmavise Corporation is seeking a seasoned clinical expert to lead and oversight clinical development programs across therapeutic areas. This remote role offers engagement with cross-functional teams and external stakeholders to drive regulatory submissions and high-quality trial execution.

Ideal candidates have a strong background in clinical research with leadership experience, GCP/ICH knowledge, and potential regulatory certification; competitive compensation is offered.