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Associate Director, Clinical Trial Management
2 months ago
Role Overview
The AD, Clinical Trial Management works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
Key Responsibilities
Clinical Operations
- 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.
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.
- Experience in Oncology Studies and/or Phase 3 trials 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.
- Experience with Phase 2 to Phase 3 studies preferred.
- 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.
Company Overview
Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at www.bicara.com.
Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.
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.
