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The Clinical Research Quality Manager (QM) manages the oncology clinical research quality management and compliance program for Alliance to ensure clinical trial integrity and compliance with regulatory requirements and guidelines. The QM proactively ensures regulatory requirements are translated into Good Clinical Practice (GCP) compliant procedures and operations. The QM manages compliance documentation submission and maintenance, GCP and clinical research compliance training, and other programmatic functions. The QM is responsible for establishing and maintaining relationships with regulatory (e.g, Food and Drug Administration) and other governmental entities (e.g, National Institutes of Health) and establishing and maintaining related policies and protocols (link removed) This position reports to the Senior Quality Manager and works closely with the Associate Director and Director, Quality Management and Audit Program, other quality management staff, regulatory compliance staff and clinical trial operations staff.

Role and Responsibilities

• Manages Alliance oncology clinical research quality management program (link removed) Promotes, improves and ensures compliance with GCP, domestic and international regulatory and industry standards. implementing risk-based methodologies to improve efficiencies to ensure clinical trial integrity, subject safety and inspection readiness at time of audit.
• Manages the development and maintenance of GCP/ICH compliant processes and Standard Operating Procedures (SOPs) for the quality, audit and inspection functions of work conducted by Alliance.
• Manages Alliance Quality Management Monitoring Committee activities.
• Drafts and implements audit plans for internal processes by anticipating problems and developing systems to identify areas of risk through internal audits.
• Uses specialized expertise to manage compliance documentation submission and maintenance, compliance training, compliance committee formation and other programmatic functions.
• Manages clinical research quality management reviews, internal and member site CAPA (Corrective and Preventative Actions
• Identifies non-conformances with requirements, providing suitable recommendations and facilitating ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols and quality management standards where applicable.
• Participates in conducting Vendor (CRO) and investigator site audits and works with vendors and investigator sites in eliminating problems via root cause analysis techniques, to ensure that quality continuously improves.
• Oversees vendors activities and performance including, review of data and quality records, such as monitoring reports, for conformance and good documentation practices (GDP)
• Develops and delivers training on health authority regulations (e.g., FDA), GCP, and inspection readiness to Alliance Investigators and internal Alliance staff.
• Supports key quality processes, metrics and indicators to measure trends and improve key quality determinants of all aspects of GCP and support GxP operations.
• Develops and manages quality monitoring and assurance process for trials submitted to regulatory authorities as part of an Investigational New Drug (IND) application and New Drug Application (NDA).
• Monitors metrics for data quality and other key performance indicators ensuring the timelines for reporting are met. Determines requirements for further monitoring/auditing as required.
• Develops guidelines to ensure compliance with trial master file requirements, staff training, sponsor obligations and other issues relevant to GCP and federal regulations for clinical trials.
• Develops policies and procedures to ensure ethical study conduct, the protection of human subjects and privacy and confidentiality of patient health information, data integrity, and data security. Review inquiries related to regulatory issues and provides guidance to internal staff and site personnel to ensure compliance with regulatory requirements.
• Manages preparation for audits and inspections of Alliance by FDA/regulatory authorities. Serves as liaison in the event of an FDA/regulatory authority inspection, or/or pharma partner audit and assists with any inspection activities, as needed.
Keeps abreast of current regulations and guidelines affecting the conduct of clinical trials by participating in national associations for regulatory personnel. Updates current processes and develops related implementation plans for policy and procedure changes.

• Supports special projects requiring quality and compliance input.
• Performs other related duties as assigned.

Requirements

• BA/BS in associated functional discipline.

• 5+ years working in a GCP Clinical Trial Quality Assurance area.
• ASQ, Auditor, CCRP, or ACRP accreditation highly desirable
• Knowledge of pharmaceutical regulations, standards, and current industry practices in GCP, Quality Management System/audit procedures, reporting and CAPA management.
• Experience including external vendor/CRO, clinical/regulatory and document auditing highly desirable.
• Experience in oncology clinical trial management highly desirable
• Experience interacting with FDA, EMA and other global health authorities.
• 100% COVID-19 Vaccinated

Preferred Skills

• Manage interpersonal relationships by interacting and communicating with clarity, tactfulness and courtesy with internal and external personnel.
• Communicate effectively, oral, written, and presentations.
• Organizational and prioritization skills
• Work effectively as a part of a team and independently with minimal supervision
• Ability to work under pressure and coordinate multiple tasks.
• Attention to detail.
• Time management, multi-tasking, problem solving, and effective communication skills.
• Proficient in MS Office suite (MS Office products, Word processing, Excel spreadsheets, e-mail management and good etiquette)

Benefits

• 100% Medical Option, Dental & Vision for employee, with 50% spouse and children - begins on the 1st day of employment
• 20 Days PTO, 5 Sick Days & 10 Holidays Off (Already Designated)
• Tuition Reimbursement
• Match 3% of a Simple IRA.
• 50% Transit or Parking paid
• Annual Employee Bonus Program
• Annual Cost of Living Increase