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Location

South San Francisco, CA | United States

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Job description

As a Senior Clinical Trial Manager, you will play a crucial role in overseeing and coordinating global clinical trials, working closely with cross-functional teams based in the US and Shanghai. Your responsibilities include leading study teams through all stages, managing project goals, and ensuring the successful delivery of high-quality clinical studies.

Key Responsibilities:

Lead and coordinate global cross-functional study teams through all study stages.
Drive the RFP and RFI process, analyze service providers, and manage complex agreements.
Provide oversight to CROs and service providers for accurate coordination of clinical study activities.
Assist with Inspection Readiness activities and contribute to the development and review of study documents.
Identify potential study issues/risks, escalate as needed, and implement effective solutions.
Manage study sites and related activities, ensuring adherence to timelines, recruitment goals, and budget.
Prepare or review clinical sections of regulatory submission documents.
Monitor study progress and initiate change orders if necessary.
Supervise ongoing communication of operational issues and provide progress reports to stakeholders.
Ensure accurate and current oversight of data and information in study-specific systems.
Communication & Interpersonal Skills:

Demonstrate high-quality written and oral communication skills.
Possess negotiation and project management skills for effective collaboration.
Ability to integrate into and collaborate with a remote cross-functional team environment.
Prioritize and handle multiple activities daily, demonstrating flexibility and responsiveness.
Model core values: Passion, Integrity, Innovation, and Patient Focus.
Core Competencies, Knowledge, and Skill Requirements:

PC literacy with proficiency in MSOffice (Outlook, Word, Excel, PowerPoint).
In-depth understanding of FDA and EU regulations, ICH Guidelines, and GCP requirements.
3 days a week on-site in the South San Francisco office (flexible).
Requirements:

Education:

Bachelor's degree or equivalent (scientific or healthcare discipline preferred).
Experience:

7+ years of experience in a biotech or pharmaceutical company.
Minimum of 3+ years of study management experience in clinical and drug development.
Experience in supporting SOP development and implementation is desired.
Experience working on global teams is desired, Asia-Pacific and EU highly preferred.
Travel:

Up to 30%
Compensation:
The target salary range for this full-time role is $155,000 - $190,000 + bonus + equity + benefits. Salary ranges are determined based on responsibilities, location, and individual factors. Further details will be discussed during the hiring process.
Employment Type: Full-Time
Salary: $ 155,000.00 190,000.00 Per Year

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Job tags

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Salary