Bicara Therapeutics · 18 hours ago
Senior Clinical Trial Manager
Boston, MA
Full-time
Hybrid
Mid, Senior Level
$150K/yr - $204K/yr
2+ years expBicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. The (Senior) Clinical Trial Manager will provide regional trial oversight within the clinical trial team, ensuring deliverables are met in terms of quality, compliance, and timing while managing vendor relationships.
BiopharmaBiotechnologyLife ScienceOncologyTherapeutics
Responsibilities
Support the clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration
Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans
Work closely with external collaboration partners with a focus on relationship management and efficiency
Lead the proactive identification, assessment, and management of clinical study challenges and risks
Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution
Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable
Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met
Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc
Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study
Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics
Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc
Contribute to and/or author clinical sections of regulatory documents including Investigators’ Brochures, safety updates, and responses to Health Authority / Ethics Committee questions
Qualification
Required
Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 2-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry
Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors
Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details
Experience and ability to manage global or regional teams in a virtual environment
Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues
Must be adaptable and enjoy working in a fast-paced environment
Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables
Willingness to travel up to 10-20% of the time
Preferred
Experience in Oncology Studies and/or Phase 3 trials preferred
Experience with Phase 2 to Phase 3 studies preferred
Company
Bicara Therapeutics
Bicara Therapeutics develops dual-action cancer therapies, combining targeted treatments with tumor modulators for enhanced impact. It is a sub-organization of Biocon.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$313MKey Investors
Biocon
2024-09-13IPO
2023-12-12Series C· $165M
2023-03-06Series B· $108M
Leadership Team
Claire Mazumdar
Chief Executive Officer
David Raben
CMO, Bicara Therapeutics
Recent News
2026-01-13
2026-01-12
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