Senior Clinical Trial Manager

🔥 14 minutes ago

🇺🇸 United States – Remote

💵 $179k - $206k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Bicara Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Bicara Therapeutics is a therapeutics-focused biotechnology company that develops novel medicines. Its website sections (Science, Patients, Investors, Careers) and the presence of an Expanded Access Policy suggest involvement in clinical research and patient access programs for investigational therapies.

📋 Description

• 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

• 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

• 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