Biopharma Clinical Operations Expert

Alpheva; United States; Remote; USD 179,000 - 276,000; Part time

Job summary

Alpheva is seeking senior clinical-operations leadership for remote, project-based engagements. The role focuses on ensuring high-quality trial management and participant protection across diverse drug-development programs.

You will evaluate planning, site operations, monitoring, and inspection-readiness, review AI-derived recommendations for feasibility and safety, and identify operational gaps aligned with ICH-GCP practices.

Qualifications

• 8+ years in sponsor, CRO, or site-level clinical operations.
• Deep knowledge of ICH-GCP, trial monitoring, site management, and protocol-deviation handling.
• Clinical program leadership or inspection-readiness experience preferred.

Responsibilities

• Evaluate clinical-trial planning, site operations, protocol execution, monitoring, and inspection-readiness decisions.
• Review AI-generated recommendations for feasibility, patient safety, data integrity, protocol compliance, and sponsor oversight.
• Identify operational gaps, missing documentation, escalation points, and conflicts with ICH-GCP practices.
• Provide corrective guidance reflecting experienced-clinical-operations leadership balancing timelines, quality, and participant protection.

Skills

ICH-GCP

Clinical operations

Trial monitoring

Site management

Leadership

Protocol deviation handling

Job description

Evaluate clinical-trial planning, site operations, protocol execution, monitoring, and inspection-readiness decisions across drug-development programs.

Review AI-generated recommendations for feasibility, patient safety, data integrity, protocol compliance, and sponsor or CRO oversight.

Identify operational assumptions, missing documentation, escalation gaps, and site-management decisions that conflict with ICH-GCP practice.

Provide clear corrections that reflect how experienced clinical-operations leaders balance timelines, quality, and participant protection.

Remote, project-based contract work. Scope and hours depend on project matching; the listed hourly range applies to matched work.

Requirements

• 8+ years in sponsor, CRO, or site-level clinical operations
• Deep knowledge of ICH-GCP, trial monitoring, site management, and protocol-deviation handling
• Clinical program leadership or inspection-readiness experience preferred

Pay

$130–$200/hr

Alpheva is a new expert network (launched September 2026); payout methods are not published yet, so confirm your first payment before scaling up.