Job Description

Senior Clinical Trial Manager

Direct Hire Full-Time Role

Salary Range: $154,000 - $175,000 per year

Location: Redwood City, CA - Hybrid Role

Duties and Responsibilities:

• Independently manage the full scope of study conduct (start-up through database lock) and coordinate cross-functional efforts to achieve study objectives and goals of complex studies (global Phase 1 and beyond)
• Collaborate cross-functionally to meet corporate goals.
• Act as a technical expert in clinical study management.
• Be responsible for the operational oversight of multiple clinical studies.
• Act as the global lead for a complex study(ies).
• Lead a Study Management Team (SMT).
• Be accountable for accurately reporting clinical study details in weekly side-by-side review slides.
• May have direct reports.
• Lead a Study Management Team.
• Perform the activities of planning, implementing, monitoring, and managing clinical trials.
• Participate in designing and developing clinical trial protocols, informed consent, case report forms, CRF completion guidelines, and Source documents as applicable.
• Work with Medical Affairs/Medical Monitor to select investigative sites, train investigators and investigative site staff, prepare materials for site initiation visits/investigator meetings, oversee clinical supplies, etc.
• May supervise and mentor CTMs, CRAs, and other operational personnel.
• Partner with the Contract Management and Outsourcing teams to develop vendor agreements, change orders, and site-specific budget templates.
• Manage and oversee external partners, consultants, vendors, and budgets to ensure the timely and cost-effective implementation of assigned projects.
• Be responsible for reviewing invoices for accuracy compared to work known to be performed by the vendors.
• May contribute to broader organization goals/or activities as assigned.
• May facilitate the selection of multiple vendors/or complex service providers in partnership with the Contract Management and Outsourcing team.
• May be responsible for implementing and managing the quality and performance management framework across assigned studies within a program, including vendor oversight activities.
• 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.
• Independently manage the full scope of 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 the clinical study(ies) to ensure the quality and integrity of data during collection, review, cleaning, and monitoring.
• Collaboratively make key decisions relating to vendors, sites, and overall study strategy.
• Be accountable for study timelines and quality metrics related to subject safety, data quality, and study integrity.
• Mentor and develop team and deliver performance reviews.
• Help to train people from CTA level to Sr. CRA/CTM.
• Perform duties with minimal supervision and partner with other team members to complete deliverables on time.

Requirements and Qualifications:

• 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
• Familiar with FDA & ICH/GCP regulations and guidelines and the process of all stages of clinical development from trial design to completion
• Proficient in computer skills and experience with Microsoft Office applications; demonstrated experience in technical writing
• Effective team player and exceptional written and interpersonal communication skills demonstrated an aptitude for strategic thinking skills.
• Demonstrated direct management experience as a study lead with vendors and clinical service providers, including CRO 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 clinical protocol, ICFs, and Study plans
• Able to utilize strong influencing skills with key stakeholders.
• Global clinical trial and CRO oversight management experience in oncology and/or ophthalmology
• Early-phase trial management experience is preferred.

Desired Skills and Experience

Clinical operations, drug development, FDA, ICH Guidelines, GCP, Microsoft Office, technical writing, study lead, CRO, vendor management, early-phase clinical trial

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