Contract Sr. CTM

Senior Clinical Trial Manager

Location: San Francisco Bay Area (Hybrid)

Company Overview

A clinical-stage biotechnology company focused on developing innovative small-molecule therapies for patients with serious chronic diseases. The organization leverages advanced structure-based and computational drug discovery technologies to design orally available medicines intended to overcome the limitations of biologics and peptide therapies. The company operates across the United States and Asia and is backed by leading global life sciences investors.

Position Summary

The Senior Clinical Trial Manager (Sr. CTM) will join the Clinical Operations group and oversee the execution of global, multicenter Phase II clinical studies. This individual will manage daily trial operations and provide leadership across internal stakeholders, CROs, vendors, clinical monitors, and investigative sites. The role requires close collaboration with cross-functional teams to ensure studies are executed on time, within budget, and in compliance with applicable regulations and company standards. Hybrid work environment with flexibility for remote arrangements.

Key Responsibilities

• Lead and coordinate global, cross-functional study teams through start-up, conduct, and close-out phases

• Drive RFP/RFI processes, evaluate vendors, review budgets and proposals, lead bid defenses, and support contract negotiations

• Provide operational oversight of CROs and external service providers

• Support inspection readiness activities and contribute to quality and compliance initiatives

• Manage and align study timelines in partnership with project management; proactively escalate risks and delays

• Lead or contribute to the development and review of study documentation (CRFs, project plans, oversight plans, TMF plans)

• Identify operational risks and implement mitigation strategies

• Oversee site-level activities including feasibility, activation, enrollment performance, monitoring oversight, and TMF quality

• Provide regular operational updates to study leadership and cross-functional stakeholders

• Partner with finance and study leadership to track vendor accruals and budget performance

• Draft and/or review clinical operations sections of regulatory submissions and responses

• Monitor scope changes and manage change orders as needed

• Maintain accurate and current data within study systems (EDC, CTMS, eTMF)

• Contribute to process improvement initiatives and operational standards

• Perform additional duties as required to support program objectives

Communication & Collaboration

• Strong written and verbal communication skills

• Proven ability to negotiate and manage complex cross-functional projects

• Comfort working in global, distributed team environments (US, EU, APAC)

• Ability to manage multiple priorities in a fast-moving environment

• Demonstrated professionalism, integrity, and patient-focused mindset

Core Skills & Knowledge

• Strong proficiency with Microsoft Office tools

• Working knowledge of FDA and EU regulations, ICH guidelines, and GCP standards

• Ability to work in a hybrid model with regular on-site presence in the Bay Area

Qualifications

Education

• Bachelor’s degree or equivalent experience (scientific or healthcare background preferred)

Experience

• 7+ years of experience in pharmaceutical or biotechnology clinical development

• 3+ years of direct study management experience, including CRO-managed trials

• Experience managing global, multinational clinical trials

• Experience contributing to SOP development and implementation preferred

• Prior experience working with APAC and European teams strongly preferred