Sr. Clinical Trials Manager

BBOT; United States; On-site; USD 130,000 - 160,000; Full time

Job summary

BBOT, a private biotech company, is seeking a Senior Clinical Trial Manager to support clinical trials in oncology. This role involves oversight of trial execution, coordination with CROs, and ensuring compliance with regulatory standards. Candidates should have significant experience in clinical operations, project management, and a strong educational background in life sciences. Join a dynamic team dedicated to developing innovative therapeutics for patients in need.

Qualifications

• Minimum 8 years of experience in Clinical Operations with CROs.
• Strong understanding of CRO/vendor oversight and clinical development process.
• Excellent project management, communication, and problem-solving skills.

Responsibilities

• Oversee global clinical trial execution including monitoring and closeout.
• Manage day-to-day operational activities ensuring quality standards.
• Support development and maintenance of key operational documents.

Skills

Project Management

Communication

Problem Solving

Education

Bachelor’s degree in life sciences or related field

Tools

EDC

CTMS

eTMF

Job description

Join to apply for the Sr. Clinical Trials Manager role at BBOT

Join to apply for the Sr. Clinical Trials Manager role at BBOT

Get AI-powered advice on this job and more exclusive features.

Description

BBOT is a private biotech company dedicated to developing innovative new therapeutics to address dire unmet needs in oncology. Founded on a commitment to patients, scientific excellence, and operational agility, we understand that every minute counts in our efforts to develop new therapies to transform the lives of people living with cancer. Driven by a team of experienced scientists, clinicians, and industry experts, our team utilizes cutting-edge structure-based drug discovery techniques to target some of oncology’s most challenging and validated molecular targets, including KRAS and PI3Ka. BBOT has a pipeline of several promising differentiated drug candidates and strong investor support, the combination of which positions us to deliver meaningful benefit to patients. Our offices and laboratory are in South San Francisco, though our colleagues and collaborators span the country and globe.

Job Type

Full-time

Description

BBOT is a private biotech company dedicated to developing innovative new therapeutics to address dire unmet needs in oncology. Founded on a commitment to patients, scientific excellence, and operational agility, we understand that every minute counts in our efforts to develop new therapies to transform the lives of people living with cancer. Driven by a team of experienced scientists, clinicians, and industry experts, our team utilizes cutting-edge structure-based drug discovery techniques to target some of oncology’s most challenging and validated molecular targets, including KRAS and PI3Ka. BBOT has a pipeline of several promising differentiated drug candidates and strong investor support, the combination of which positions us to deliver meaningful benefit to patients. Our offices and laboratory are in South San Francisco, though our colleagues and collaborators span the country and globe.

Who You Are

We are seeking a Senior Clinical Trial Manager (Sr. CTM) to support the execution of BBOT’s clinical trials across all phases, with a focus on early-phase oncology. Reporting to the Associate Director of Clinical Operations, the Sr. CTM will play a critical role in supporting cross-functional planning, day-to-day oversight of trial activities, and ensuring the delivery of high-quality, timely clinical data. The Sr. CTM will work closely with internal and external partners, including CROs, vendors, and clinical sites. Global trial experience a plus.

Responsibilities

• Support the Associate Director in overseeing global clinical trial execution, including site activation, enrollment, monitoring, and closeout
• Support the Associate Director in leading cross functional trial team meetings and ensure alignment on key deliverables, timelines, and risk mitigation strategies.
• Manage day-to-day operational activities for assigned studies, ensuring adherence to timelines, budgets, and quality standards
• Drive vendor integration strategies to ensure seamless execution between CRO, central labs, and any specialty service providers.
• Act as the main clinical operations point of contact for assigned study-level tasks, including managing CROs and vendors in collaboration with the Associate Director
• Ensure completeness and inspection-readiness of the trial master file (TMF/eTMF)
• Support the development and maintenance of key operational documents including study manuals, ICFs, tracking tools, and monitoring plans
• Participates in the conduct of audits and support regulatory inspections related to GCP
• Monitor regulatory and GCP compliance across trial activities and support audit/inspection readiness
• Review clinical trial data listings to support identification and resolution of protocol deviations, data trends, and outstanding queries
• Own CRO and vendor oversight by tracking deliverables, proactively identifying risks until issue resolution, and performance metrics in partnership with the Program/Study Lead
• Oversee lab sample management processes, including sample tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens
• Contributes to continuous process improvement and SOP development
• Participate in team meetings, providing clinical operations insights and updates to internal stakeholders
• Mentor junior team members as needed to build internal operational capabilities
  
  

Requirements

• Bachelor’s degree in life sciences or related field
• Minimum 8 years of experience in Clinical Operations, working with CROs and other vendors
• Strong understanding of CRO/vendor oversight and clinical development process
• Early-phase oncology experience preferred
• Prior experience in a lean or startup environment is highly desirable
• Excellent project management, communication, and problem-solving skills
• Working knowledge of ICH-GCP and global regulatory requirements
• Proficient in clinical trial systems (e.g., EDC, CTMS, eTMF) and Microsoft Office Suite
• Excellent project management, communication, and problem-solving skills

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

Referrals increase your chances of interviewing at BBOT by 2x

Get notified about new Senior Clinical Trial Manager jobs in United States.

Manager – Research Operations and Patient Engagement

United States $100,000.00-$130,000.00 1 month ago

United States $75,000.00-$85,000.00 1 week ago

Clinical Program Operations Manager, Therapeutics & Innovations

Clinical Research Operations Manager 182825

Associate Director/Director, Clinical Operations, Autoimmune

South San Francisco, CA $180,000.00-$240,000.00 8 months ago

United States $160,000.00-$180,000.00 18 hours ago

United States $58,000.00-$65,000.00 2 days ago

United States $136,200.00-$152,200.00 1 day ago

Associate Director / Director, Clinical Operations

South San Francisco, CA $170,000.00-$235,000.00 2 days ago

Sr Mgr, Clinical Trial Budgets & Contracts

Senior Manager, Clinical Operations Site Partner (West/Central CSP)

United States $170,000.00-$200,000.00 2 weeks ago

Senior Clinical Research Manager- HealthTech

United States $99,500.00-$156,420.00 2 weeks ago

Clinical Quality and Process Excellence Lead

Senior Clinical Quality Assurance Manager

San Francisco, CA $85.00-$99.00 3 days ago

Senior Clinical Quality Assurance Manager

Sr. Manager, Clinical Program Management, Clinical Operations

Basking Ridge, NJ $85.00-$99.00 3 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.