(Senior) Clinical Trial Manager

Bicara Therapeutics•Boston, MA

2d•Hybrid

About The Position

The (Senior) Clinical Trial Manager will be based in Boston and work within the clinical trial team to provide trial oversight in the European region. They will ensure deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Associate Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

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.
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.

Nice To Haves

Experience in oncology studies and/or Phase 3 trials highly preferred.
Experience with Phase 2 to Phase 3 studies highly preferred.

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.