Senior Clinical Trial Manager (Global)
Bicara Therapeutics
June 30, 2026
Remote friendly (Boston, MA)
United States
$179,000 - $211,000 USD yearly
Clinical Research and Development
Responsibilities:
- Execute Bicara’s clinical operations strategy for high-touch, patient-centered clinical trials with a focus on adaptive/seamless designs to support registration.
- Ensure trial deliverables are met on timelines, budget, procedures, and quality standards; may include drafting study documents (e.g., lab manual sections), developing study tools/guidelines/training, managing clinical study materials, and implementing issue resolution plans.
- Build relationships and work efficiently with external collaboration partners.
- Proactively identify, assess, and manage clinical study challenges and risks.
- Support oversight of study activities: site identification/selection, enrollment models, clinical supply planning, budget planning, and trial execution.
- Monitor CRO/third-party vendor performance and compliance via regular contact with vendors (e.g., CRAs) as applicable.
- Partner with CRO to develop/revise SOWs, budgets, plans, and detailed timelines; ensure performance expectations are met.
- Contribute to and author study documents (protocol, investigator brochure, informed consent, etc.).
- Participate in Case Report Form design/UAT with Data Management and support data monitoring.
- Oversee study management/clinical development teams (including CROs) to meet quality metrics.
- Execute CRO/third-party oversight (e.g., monitoring report review, data quality review, CRO/vendor KPI review, Sponsor Oversight Visits).
- Author/contribute to regulatory clinical sections (Investigators’ Brochures, safety updates, responses to Health Authority/EC questions).
- May manage a team of Clinical Trial Associates (hiring and professional development).
Qualifications:
- Bachelor’s degree (preferably Life Sciences: Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum 5 years clinical trial management experience (pharma/biotech and/or CRO).
- Demonstrated ability to manage global clinical trials across regions, navigating regulatory requirements, cultural nuances, and varied site capabilities.
- Strongly preferred: Phase 2/Phase 3 experience.
- Strongly preferred: Oncology experience.
- Clinical research operational knowledge; computer literacy; strong project planning/management with CRO/vendor oversight.
- Global clinical trial management experience in fast-paced CRO outsourced environments.
- Experience managing global/regional teams virtually.
- Strong decision-making, communication/collaboration, analytic, and issue-resolution skills.
- Adaptable, comfortable in fast-paced environments; effective leadership and team productivity/quality focus.
- Travel up to 10–20%.
Compensation Range: $179K - $211K
- Execute Bicara’s clinical operations strategy for high-touch, patient-centered clinical trials with a focus on adaptive/seamless designs to support registration.
- Ensure trial deliverables are met on timelines, budget, procedures, and quality standards; may include drafting study documents (e.g., lab manual sections), developing study tools/guidelines/training, managing clinical study materials, and implementing issue resolution plans.
- Build relationships and work efficiently with external collaboration partners.
- Proactively identify, assess, and manage clinical study challenges and risks.
- Support oversight of study activities: site identification/selection, enrollment models, clinical supply planning, budget planning, and trial execution.
- Monitor CRO/third-party vendor performance and compliance via regular contact with vendors (e.g., CRAs) as applicable.
- Partner with CRO to develop/revise SOWs, budgets, plans, and detailed timelines; ensure performance expectations are met.
- Contribute to and author study documents (protocol, investigator brochure, informed consent, etc.).
- Participate in Case Report Form design/UAT with Data Management and support data monitoring.
- Oversee study management/clinical development teams (including CROs) to meet quality metrics.
- Execute CRO/third-party oversight (e.g., monitoring report review, data quality review, CRO/vendor KPI review, Sponsor Oversight Visits).
- Author/contribute to regulatory clinical sections (Investigators’ Brochures, safety updates, responses to Health Authority/EC questions).
- May manage a team of Clinical Trial Associates (hiring and professional development).
Qualifications:
- Bachelor’s degree (preferably Life Sciences: Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum 5 years clinical trial management experience (pharma/biotech and/or CRO).
- Demonstrated ability to manage global clinical trials across regions, navigating regulatory requirements, cultural nuances, and varied site capabilities.
- Strongly preferred: Phase 2/Phase 3 experience.
- Strongly preferred: Oncology experience.
- Clinical research operational knowledge; computer literacy; strong project planning/management with CRO/vendor oversight.
- Global clinical trial management experience in fast-paced CRO outsourced environments.
- Experience managing global/regional teams virtually.
- Strong decision-making, communication/collaboration, analytic, and issue-resolution skills.
- Adaptable, comfortable in fast-paced environments; effective leadership and team productivity/quality focus.
- Travel up to 10–20%.
Compensation Range: $179K - $211K