Tosoh Bioscience, Inc., based in South San Francisco, CA is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists.
Summary
Position Profile: Under the direction of the Director of Regulatory, the Clinical Affairs Manager (IVD) is responsible for the planning, execution, and oversight of multiple clinical and analytical studies across various sites. This role ensures compliance with all regulatory and contractual requirements and manages the operational aspects of clinical studies within the defined scope of work. The Clinical Affairs Manager guarantees that studies are conducted in accordance with protocols, standard operating procedures (SOPs), and applicable regulatory guidelines. As part of this role, the Clinical Affairs Manager leads the protocol development as well as final study report completion, site/investigator selection, study initiation and termination activities.
Reporting Relationships
Reports to: Director of Regulatory and has direct reports.
Major Duties and Responsibilities
- Must have 10 + years experience in clinical and analytical study management.
- Must have 5 + years of clinical research experience in the in-vitro diagnostic medical device industry, including on-site and remote monitoring. Develop and evaluate clinical and analytical study protocols, including development of study related clinical documentation, overall clinical plan, drafts protocols, collaborate on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies and/or defending clinical/analytical outcomes with internal and external stakeholders.
- Provide leadership and performance management for the clinical team, ensuring adherence to protocols and delivery of high-quality support.
- Monitor individual and team performance metrics; conduct regular team meetings and one-on-one check-ins to address challenges and drive results.
- Design and implement study-specific monitoring and reporting procedures, methods, guidelines, and tools; establish baseline parameters and edit check specifications, and in the development of subject tracking systems.
- Submits study protocols for all associated study sites/participants to central Investigational Review Board (IRB) for approval or grant of waiver, resolves requests for additional data and ensures timely renewal or termination of IRB approvals.
- Identify and evaluate potential investigators and clinical/analytical sites, both nationally and internationally; conduct pre-study site visits, collects and reviews data, and prepares evaluative reports; makes final selection of investigators and study sites.
- Assess and recommend contract research organizations (CROs) based on qualifications and experience relevant to proposed research activities.
- Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; conducts site meetings and multicenter investigator meetings and prepares reports.
- Perform site monitoring visits and follow-ups to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines, and policies.
- Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies and provides remedial training and/or initiates corrective action as required.
- Oversee transmission and review of clinical case data; resolve queries and discrepancies to maintain data integrity.
- Manage termination of clinical studies by identifying and assigning items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
- Lead and evaluate internal clinical team and set expectations for clinical team
- Maintain timely and effective communication, to include project debriefing presentations and form good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures.
- Performs miscellaneous job-related duties as assigned.
- Upholds and adheres to the Tosoh America culture and guiding principles.
Education
Skills and Qualifications
- Minimum of 10 years in clinical and analytical study management
- Minimum of 5 years of clinical research experience in the in-vitro diagnostic medical device industry, including on-site and remote monitoring.
- Strong knowledge of ICH/GCP as well as CLSI and FDA regulations and ability to translate requirements into study protocols and reports.
- Knowledge of clinical and analytical study principles, methodology, and procedures.
- Knowledge of all federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
- Ability to independently develop and apply concepts and techniques in clinical research monitoring.
- Ability to develop and implement clinical and analytical study monitoring plans and standard operating procedures.
- Strong clinical and analytical study/project management skills
- Skill in the use of statistical, technical, and database applications.
- Knowledge of statistical data collection, editing, validation, and analysis techniques.
- Knowledge of laboratory certification standards and processes.
- Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards.
- Ability to develop technical reports and manuscripts.
- Ability to make evaluative judgments.
- Ability to motivate and collaborate with cross functional teams.
- Knowledge of industrial standards as applied to good clinical practices.
- Knowledge of patient care charts and patient histories.
- Ability to develop and deliver both oral and written presentations to stakeholders, executive management and/or regulatory bodies.
- Ability to communicate and interact competently and professionally at all levels within a broad clinical and analytical research environment.
- Ability to establish data collection and management guidelines.
- Knowledge of database concepts, and formats.
- Ability to travel up to 5-10%
Physical Requirements
- The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to travel by auto and air, including international. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Working Conditions
- This position requires visits to customer sites which are medical facilities. These facilities may have certain requirements which TOSOH representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings.
- Must agree to provide required immunization records or agree to acquire required immunizations to gain access to customer sites, as required by, customers. You may be required to register at vendor credentialing companies.
Tosoh Bioscience, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans
