Senior Clinical Trial Manager – Global

Role Overview

• 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.
• 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 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.

Benefits

• medical, dental, and vision coverage upon hire
• short term and long term incentives including cash bonus and equity incentive opportunities
• comprehensive benefits and wellness package