The role leads defined safety science activities for assigned cell therapy assets, integrating safety data, supporting benefit-risk decisions, and managing patient risks across the product lifecycle.
Compensation
The annual base pay for this position ranges from $132K to $199K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Conduct and coordinate safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets.
Develop MedDRA search strategies with appropriate guidance.
Translate emerging safety data into clear analyses and recommendations for asset teams.
Lead defined components of pharmacovigilance and risk-management planning, including RMPs, REMS, risk-minimization tracking and benefit-risk assessments.
Author and project-manage aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS and ad hoc analyses.
Requirements
Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
Assesses site processes, conducts Source Document Review, verifies required clinical data entered in the case report form (CRF) is accurate and complete.
Applies query resolution techniques remotely and on site, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
Requirements
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site.
Conducts Source Document Review of appropriate site source documents and medical records.
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
As Manufacturing Compliance Superintendent, you lead a team of CAPA writers and investigators to improve execution of the quality system, improve existing processes, and identify solutions to prevent nonconformances.
Compensation
The estimated base salary for this position is $90,000 - $115,000 annually.
Responsibilities
Ensure nonconformance and exceptions are initiated and completed timely
Develop, implement, and maintain procedures and systems to ensure compliance with regulatory requirements
Provide strategic leadership for batch release, control systems, documentation updates, investigations, and CAPAs
Design and deliver comprehensive updates to existing procedures and controls
Conduct risk assessments and establish trend reviews
Requirements
Bachelor’s degree or equivalent experience in Chemistry, Pharmaceutical Sciences, or a related scientific field
The Clinical Data Coordinator will participate in various clinical data management activities to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed and reported clearly, accurately and securely.
Responsibilities
Provides general data management support to the project team, sponsor and external vendors, as needed.
Supports Lead Data Manager in Data Review
Data Reconciliation
Discrepancy Management
Maintenance of Study Metrics; Monitoring study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.
Biostatistician supporting clinical trials through statistical analysis, programming, and data interpretation. Using SAS to support scientific decision-making, clinical study design, and device safety evaluation.
Compensation
Minimum Salary: $ 71500 Maximum Salary: $ 135800
Responsibilities
Generate statistical summary tables, patient data listings and clinical trial reports using SAS
Perform quality control reviews of SAS programs
Troubleshoot complex SAS programming challenges
resolve study-related programming issues
Compile, organize and analyze clinical trial data
Requirements
Bachelor's level degree with relevant experience
Master's degree in biostatistics, statistics, public health or a related field preferred
comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability)
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