Senior Clinical Trial Manager

Bayside Solutions; Fremont (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Bayside Solutions in Redwood City, CA, is seeking a motivated Clinical Operations professional to oversee end-to-end study execution in compliance with FDA and ICH guidelines. The role involves coordinating cross-functional teams, vendors, and study milestones to meet objectives and budgets.

You’ll develop study plans, track timelines and metrics, report to senior management, identify risks, and ensure data quality from start-up through close-out, with domestic/international travel up to 25%.

Qualifications

• 3-5 years of experience in clinical and drug development.
• BS/BA in Life Sciences or related discipline.
• Strong knowledge of FDA & ICH/GCP regulations.

Responsibilities

• Manage the execution of clinical studies, with milestones, timelines and vendor selection.
• Prepare timely study updates and reports for senior management.
• Identify risks and implement mitigation strategies.
• Oversee start-up, treatment, maintenance and close-out stages.
• Ensure data quality and regulatory compliance (FDA/ICH/GCP).

Skills

Team collaboration

Written & verbal communication

Strategic thinking

Time management

Cross-functional collaboration

Education

BS/BA in Life Sciences

Tools

MS Office

Job description

Location: Redwood City, CA - Hybrid Role

Job Summary:

We are seeking a highly motivated individual to join our Clinical Operations team. This individual will be responsible for the overall execution of clinical study(ies) from initial concept through study completion, in accordance with all applicable regulations governing the conduct of clinical trials. Overall responsibilities may include the management of clinical operations activities and coordinating cross-functional efforts in the administration and progress of a clinical trial(s) in order to achieve trial objectives and corporate goals.

Duties and Responsibilities:

• Manage the implementation, on-time execution, and conduct of clinical study(ies), including the development of study plan(s), key milestones, timelines, study costs, and vendor selection while ensuring the highest level of quality and compliance.
• Prepare and deliver accurate and timely study updates, metrics, and reports to senior management.
• Ability to identify potential risks that may impact the study(ies), e.g., study data, ethical conduct, and adherence to ICH guidelines, and provide risk mitigation solutions.
• Appropriately manage the various stages of study activities, e.g., start-up, treatment, maintenance, and close-out, to ensure the study is conducted on time and within budget.
• Understand the data requirements of clinical study(ies) to ensure quality and integrity of data during collection, review, cleaning, and monitoring.
• Perform responsibilities with a high degree of independence while effectively partnering with team members to meet deliverables and deadlines.

Requirements and Qualifications:

• Effective team player with exceptional written and interpersonal communication skills.
• Demonstrated aptitude for strategic and flexible thinking, with the ability to anticipate challenges, evaluate alternatives, and adjust strategies as needed.
• Proven ability to manage delegated aspects of clinical trials, leveraging strong planning, organizational, and time‑management skills.
• Ability to manage CROs and clinical study vendors.
• Ability to collaborate with cross-functional clinical study teams.
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines, and ability to translate into inspection readiness at all times.
• Proficiency in MS Office, including Word, Excel, PowerPoint, and other applications; demonstrated experience in technical writing.
• Travel Requirements: domestic and/or international up to 25%.
• BS/BA in Life Sciences or related discipline.
• 3-5 years of experience in clinical and drug development.

Desired Skills and Experience

Clinical trial management, clinical operations, clinical study execution, study planning, milestone and timeline management, study budgeting, vendor selection, CRO management, clinical vendor oversight, study start-up, treatment, maintenance and close-out, clinical data quality and integrity, data review and cleaning, clinical monitoring, risk identification and mitigation, FDA regulations, ICH-GCP compliance, inspection readiness, cross-functional collaboration, study metrics and reporting, technical writing, strategic planning, project management, organizational skills, time management, written and interpersonal communication, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, life sciences, clinical development, drug development

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