Sr Manager, Clinical Project Management

Cg Oncology • Irvine, CA

218d • $153,000 - $180,000 • Remote

About The Position

The Sr. Manager, Clinical Project Management is responsible for hands on day-to-day management of a diverse and complex program of clinical trials directly and with subordinate staff, including the ability to influence and manage contract CROs conducting company-sponsored clinical trials, while ensuring the operational strategy and implementation are consistent with protocol, regulatory, budgetary, and quality objectives. The Sr. Clinical Project Manager reports directly to the Director, Clinical Operations and helps lead phase I-III studies in North America and globally.

Requirements

• Bachelor's Degree in a life science or a health-related field.
• Seven (7) years or more of progressive clinical management experience with the biotech/pharmaceutical industry or in a clinical research organization.
• Three (3) years of experience in full-cycle drug development required including participation in multi-disciplinary project teams working on phase I-IV global clinical studies.
• Prior experience supporting regulatory filings, inspections, and audits.
• Available for approximately 25% travel both domestic and international, including overnight stays.

Responsibilities

• Manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications.
• Partners with the Clinical Research Organization (CRO) to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives.
• Oversees all study-level data monitoring activities; reviews visit reports; attends monitoring visits as required.
• Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review.
• Responsible for coordination and oversight of clinical data and listings review for assigned trials.
• Works in a team environment comprising of clinical operations, regulatory, technical operations, quality, and CROs to assess and meet data management needs.
• Uses operational and therapeutic expertise to optimize trial design and execution.
• Prepares and/or reviews study-related documents.
• Responsible for the management of study budget and maintains it within financial goals.
• Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs.
• Participates in the selection, training, and evaluation of study personnel (contract and internal).
• Mentors, leads and supervises other Clinical Trials roles to achieve both role and team objectives.

Benefits

• Highly competitive salaries
• Annual performance/merit reviews
• Annual performance bonuses
• Equity
• Special recognition
• Fully remote work environment
• Unlimited flexible time off
• 14 holidays in 2025
• 401K with 100% company Safe Harbor match up to 4% of base salary
• Health (medical, dental, vision) - PPO & HDHP - Cigna/Principal
• Health spending accounts - HSA (with annual company contribution), FSA, FSA-DC
• Company paid LTD coverage + voluntary plans
• Company paid life insurance 1x base salary + voluntary plans
• Voluntary legal, pet, plus more

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Administration of Human Resource Programs
• Education Level: Bachelor's degree