Senior Clinical Trial Manager

Bicara Therapeutics

. Execute Bicara’s clinical operations strategy for high-touch, patient-centered clinical trials with adaptive and seamless designs .

Posted 9/17/2026full-timeRemote • United StatesSenior💰 $179,000 - $206,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing global clinical trials, ensuring compliance with regulatory standards, and delivering high-quality patient-centered outcomes. Proficient in project planning, CRO oversight, and developing clinical study documentation.

Highest-signal resume keywords

Clinical Trial ManagementCRO OversightProject PlanningRegulatory ComplianceOncology Study Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research Operational KnowledgeStudy Document DevelopmentBudget PlanningData MonitoringIssue Resolution PlanningUser Acceptance TestingKPI ReviewClinical Supply PlanningEnrollment ModelsProtocol Authoring

Soft Skills

Strong Decision-MakingEffective LeadershipCollaborationCommunicationAdaptability

Industry Keywords

Life SciencesPharmaceuticalBiotechCROPhase 2 StudyPhase 3 StudyGlobal Clinical TrialsVirtual Team ManagementHealth Authority ComplianceEthics Committee

About the role

Key responsibilities & impact

Execute Bicara’s clinical operations strategy for high-touch, patient-centered clinical trials with adaptive and seamless designs
Ensure trial deliverables meet timelines, budget, operational procedures, and quality standards
Develop study-document sections, study tools, guidelines, and training materials
Manage clinical study materials and implement issue-resolution plans
Manage relationships with external collaboration partners
Identify, assess, and manage clinical study challenges and risks
Oversee site identification and selection, enrollment models, clinical supply planning, budget planning, and trial execution
Monitor CRO and third-party vendor study progress and regulatory compliance
Develop or revise CRO scope-of-service agreements, budgets, plans, and timelines
Participate in authoring protocols, investigator brochures, informed consents, and other study documents
Participate in Case Report Form design, user acceptance testing, and data monitoring
Oversee CROs and clinical development teams to achieve clinical development goals and study quality metrics
Perform CRO/third-party oversight activities, including monitoring visit report review, data-quality review, KPI review, and Sponsor Oversight Visits
Contribute to or author clinical sections of regulatory documents and responses to Health Authority/Ethics Committee questions
Potentially manage Clinical Trial Associates, including hiring and career and professional development

Requirements

What you’ll need

Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 5 years’ clinical trial management experience in the pharmaceutical, biotech and/or CRO industry
Demonstrated ability to manage global clinical trials across multiple geographies
Clinical research operational knowledge and computer literacy
Strong project planning and management, including oversight of CROs/vendors
Global clinical trial management in a fast-paced CRO-outsourced environment
Experience and ability to manage global or regional teams in a virtual environment
Strong decision-making, communication, collaboration, and analytical skills
Adaptability and ability to work in a fast-paced environment
Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables
Phase 2/Phase 3 study experience strongly preferred
Oncology study experience strongly preferred

Benefits

Comp & perks

Short-term incentives, including cash bonus
Long-term incentives, including equity incentive opportunities
Medical coverage upon hire
Dental coverage upon hire
Vision coverage upon hire
Comprehensive benefits and wellness package