Senior Clinical Trial Manager (Study Oversight)

Company: Confidential

Job description

Senior Clinical Trial Manager (Study Oversight, 3 Programs)

Engagement: Contract, 6-12+ months

Commitment: 40 hours/week, Monday-Friday, 8am-4pm Pacific.

This is a dedicated role with limited schedule flexibility.

Location: Remote

Client Overview

A biotechnology company with a multi-program clinical pipeline.

Business Driver

The company has three programs that need dedicated oversight to meet study timelines.

The Work

Provide study oversight across three programs, including:

Key vendor oversight and performance management

Serve as the primary operational contact for CROs and vendors, monitoring deliverables, timelines, and quality metrics
Proactively manage vendor performance, identifying risks or delays and implementing mitigation strategies
Review vendor status reports, dashboards, and KPIs to ensure accountability and adherence to contract terms

Timeline and milestone tracking

Drive execution of study activities, ensuring on-time delivery of critical milestones (enrollment, monitoring, data lock, etc.)
Escalate issues early, coordinate resolution, and maintain transparency across teams
Develop and track operational timelines, highlighting dependencies between vendors and internal functions

Internal stakeholder management

Collaborate with cross-functional teams (Regulatory, Clinical Development, Data Management, Medical Writing, etc.) to align priorities
Communicate study progress, risks, and contingency plans clearly to leadership and key stakeholders
Synthesize complex updates into concise, actionable summaries to support efficient decision-making

Leadership and communication

Balance firmness with diplomacy in both vendor and internal interactions
Build trust through consistent, solution-oriented communication with study teams and governance committees
Represent Clinical Operations with credibility, ensuring alignment between strategic objectives and tactical execution

Professional Requirements