Clinical Trial Manager / Senior Clinical Trial Manager

Clinical Trial Manager / Senior Clinical Trial Manager

W2 Contract-to-Hire

Salary Range: $156,000 - $187,200 per year

Location: Redwood City, CA - Hybrid or Remote PST

Job Summary:

This role is a unique opportunity for an experienced Clinical Operations Professional with technical expertise in managing Phase I-III clinical trials in an industry setting and who has a strong knowledge of clinical operations, Good Clinical Practice (GCP), and US Food and Drug Administration (FDA) regulatory requirements. As a Clinical Program Manager, you will be responsible for Contract Research Organization (CRO) oversight and the execution of clinical studies.

Duties and Responsibilities:

• Perform clinical operations functional activities related to the execution of assigned clinical trials based on department and corporate goals and objectives.
• Manage clinical studies and vendors to ensure studies are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and International Council for Harmonization (ICH)/ GCP guidelines.
• Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) providers, and independent contractors) to execute clinical trials.
• Review and contribute to developing study-specific documentation, including clinical trial protocols, case report forms, study guides/manuals, informed consent forms, and clinical databases.
• Review monitoring reports and other study documentation as required.
• Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
• Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
• Follow up on assigned team action items and identify, escalate, and resolve issues as needed.
• Collaborate with contract specialists to review and negotiate clinical trial agreements and site-specific study budgets.
• Assess the adequacy and feasibility of potential clinical investigators and sites, including evaluating facilities, personnel, patient referral base, and adherence to GCP.
• Develop clinical study monitoring priorities and Monitoring Plan in conjunction with CRO.
• Conduct site visits (e.g., training visits, site initiation visits, monitoring visits) as required.
• Manage investigational product accountability and the reconciliation process.
• Assist with preparing safety, interim, and final clinical study reports and resolving data discrepancies.
• Provide clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.
• Prepare and track study participant enrollment projections vs. actuals and study budgets.
• Serve as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.

Requirements and Qualifications:

• BS or MS degree with a minimum of 5+ years of clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in Oncology drug development
• Hands-on experience in running early-stage clinical trials within an industry environment
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Experience in the selection of CROs and vendors and management of external resources.
• A demonstrable record of solid vendor management and teamwork
• Direct experience in managing clinical CROs
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Excellent written and verbal communication skills
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is crucial.
• Able to travel (~25%)
• Oncology experience is preferred.
• Experience in working with cooperative group studies and investigator-sponsored trials is preferred.
• Experience in global clinical trial operations is a plus.
• Knowledge of APAC regulations is highly desired.

Desired Skills and Experience

Clinical trial, Phase I-III, drug development, Oncology, GCP, FDA, ICH, vendor management, travel, APAC

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