Senior Clinical Trial Manager

Direct Hire Full-Time Role

Pay Rate: $79 - $89 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

We are seeking a highly motivated individual to join the Clinical Operations team. This individual is 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:

• Manages the implementation, on-time execution, and conduct of clinical study(ies), including the development of study plan(s), key milestones, timelines, study costs, vendor selection, as well as ensuring quality and compliance
• Provides effective study updates and tracking of progress 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.
• Understands the data requirements of clinical study(ies) to ensure quality and integrity of data during collection, review, cleaning, and monitoring
• Performs duties with minimal supervision and has the ability to partner with other members of the team to complete deliverables on time

Requirements and Qualifications:

• Effective team player with exceptional written and interpersonal communication skills.
• Demonstrated aptitude for strategic thinking skills
• Ability to manage delegated aspects of assigned clinical trials
• Ability to manage CROs and clinical study vendors
• Ability to influence and collaborate with cross-functional clinical study teams
• Strong planning and organizational skills
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines
• Proficiency in MS Office, including Word, Excel, PowerPoint, and other applications; demonstrated experience in technical writing
• Travel Requirements: internationally up to 25%
• BS/BA in Life Science or related discipline
• 6+ years of clinical operations experience or related drug development
• 2+ years at a sponsor company
• 1+ years as global study lead
• Familiarity with FDA & ICH/GCP regulations and guidelines, and the process of all stages of clinical development from trial design to completion
• Proficiency in computer skills and experience with Microsoft Office applications; demonstrated experience in technical writing
• An effective team player with exceptional written and interpersonal communication skills, demonstrating an aptitude for strategic thinking.
• Demonstrated direct management experience as a study lead with vendors and clinical service providers, including CROs identification, selection, and management
• Ability to manage delegated aspects of assigned clinical trials
• Ability to influence and collaborate with cross-functional clinical study teams
• Strong clinical studies planning and organizational skills
• Demonstrated experience in technical writing, including but not limited to clinical protocol, ICFs, Study plans, etc.
• Utilize strong influencing skills with key stakeholders.
• Global clinical trial and CRO oversight management experience in oncology

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