Senior Clinical Trial Manager

Bicara Therapeutics; Boston; On-site; PHP 6,027,728 - 7,836,046; Full time

Job summary

Bicara Therapeutics is looking for a Senior Clinical Trial Manager (Global) based in Boston to lead operational execution for clinical trials. The role involves managing clinical operations, ensuring adherence to timelines and quality standards. The candidate will collaborate with cross-functional teams and external partners, facilitating vendor oversight and risk management.

Applicants should have a Bachelor's Degree in Life Sciences and 5+ years of relevant experience in trial management. The position allows for a hybrid work schedule with three days in the office each week.

.

Qualifications

• 5+ years of clinical trial management experience in pharmaceutical or biotech.
• Experience managing global clinical trials and navigating regulatory requirements.
• Strong decision-making, communication, and collaboration skills.

Responsibilities

• Oversee clinical trial operations and ensure compliance with quality standards.
• Manage relationships with external partners and vendors.
• Lead risk management and proactive identification of study challenges.

Skills

Clinical trial management

Project planning

Regulatory knowledge

Leadership skills

Analytical skills

Education

Bachelor's Degree in Life Sciences

Job description

Position Overview

Bicara Therapeutics is seeking a Senior Clinical Trial Manager (Global) to oversee multiple regions and help lead the operational execution required to bring our science to patients. In this role, you will own day-to-day management of one or more clinical trials, partnering closely with cross-functional teams, clinical sites, and CRO partners to ensure studies are executed while maintaining the highest standards of quality and compliance. You will be a key driver of vendor oversight, site performance, and risk management – anticipating challenges before they arise and building the internal and external relationships needed to move our trials forward. You will work alongside a tight-knit, mission-driven team that values collaboration, respect, and urgency.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• Execute Bicara’s 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.
• May be responsible for managing a team of Clinical Trial Associates including hiring and career and professional development.

Qualifications

• 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, navigating regional regulatory requirements, cultural nuances, and varying site capabilities across multiple geographies.
• Phase 2/Phase 3 study experience strongly preferred.
• Oncology study experience strongly preferred.
• Clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
• Global clinical trial management in fast paced CRO outsourced environment required.
• 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.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.