Clinical Trial Manager

Summary

Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s).

The CTM reports to the Associate Director, Clinical Operations. The ideal candidate should have B.S. degree in science or healthcare and a minimum of five years of research experience.

Responsibilities

• Leads tasks as assigned by manager with decisiveness and strong judgment.
• Manages CROs and other Visterra vendors to ensure tasks are completed on time and within budget.
• Works closely with internal cross-functional study execution team to facilitate smooth execution of early phase clinical trials
• Identifies any potential risks and escalates to manager with mitigation solutions.
• Leads document finalization process with both internal and external stakeholders to ensure all comments / feedback incorporated.
• Draft and / or assist in development of clinical study documents including ICF, study plans, and pharmacy manual.
• Ensures that all clinical data is managed and completed in a timely manner. Monitors vendor systems, develops tracking tools, and reports as appropriate to distribute to study team.

Preparation and oversight of Trial Master File (TMF) and internal files, including periodic reviews as per TMF plan.

• May participate in regulatory audits and inspections as appropriate.
• Hosts internal study meetings, including the development of agenda, slides, and minutes.

Requirements

• Science, healthcare, or related bachelor's degree required
• At least 5 years of clinical research experience at a pharmaceutical / biotech or CRO, with at least two years of clinical study management experience
• Strong knowledge and understanding of GCP / ICH Guidelines and relevant CFRs for conducting clinical trials
• Effective communication (written and verbal), adaptability and self-motivation
• Ability to balance changing priorities
• Strong interpersonal, organizational, and multi-tasking skills
• Excellent attention to detail and problem-solving skills
• Ability to work equally effectively remotely and in-person
• Computer proficiency, including Microsoft Office applications. Experience with EDC, TMF, and CTMS systems.
• Ability and willingness to travel, usually less than 15% of the time.

Company

Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases.

Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets.

Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly-owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co.

Ltd. of Japan. Visterra has approximately 115 employees and is in Waltham, Massachusetts.

Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.