Senior Clinical Trial Manager
Bicara Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $150,000 - $204,000 per year
Job Level
About the role
- 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.
Requirements
- Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum of 3-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry.
- Experience in oncology studies and/or Phase 3 trials highly preferred.
- 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.
Benefits
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementproject planningdata monitoringCase Report Form designregulatory document authorshipbudget planningrisk managementstudy document developmentclinical supply planningissue resolution
Soft Skills
decision-makingcommunicationcollaborationanalytical skillsadaptabilityleadershiprelationship managementteam productivityproblem-solvingorganizational skills