Clinical Quality Manager

**About the role**
Curebase is seeking a Clinical Quality Manager who will thrive in a quickly scaling healthcare technology environment. The Quality and Compliance team at Curebase is deeply collaborative, and you will collaborate with Clinical Operations, while leading and mentoring the Clinical Quality team. This role reports directly to the Director of Quality.
What you'll do
- Lead, mentor and grow a diverse QA team of Clinical Quality Associates.
- Lead the identification and implementation of clinical quality improvement initiatives
- Support the development and implementation of SOPs, templates and policies related to clinical quality management
- Provide advice and support regarding interpretation of internal SOPs and applicable regulations (e.g., ICH-GCP, US CFR) to ensure quality and regulatory compliance
- Oversee quality assurance reviews of clinical trial documentation (e.g., essential documents, clinical database, training records) to confirm adequate quality
- Perform initial and recurring risk identification, assessment, and mitigation activities
- Manage non-compliance (e.g., regulatory, protocol, SOP) and clinical quality issues, ensuring appropriate actions and documentation (e.g., incident reports, CAPAs)
- In collaboration with Clinical Operations and the Director of Quality, ensure trials are inspection ready at all times
- Host and participate in activities related to client audits and regulatory inspections
- Participate in the evaluation and qualification of external partners (e.g., clinical sites, vendors), including conducting audits (remote or in-person) on an as needed basis
- Contribute to the oversight and maintenance of controlled documents related to clinical quality assurance within the Quality Management System
- Assist in tracking and assessment of clinical quality compliance metrics to identify risks and trends across clinical trials
- Provides effective communication regarding issues, objectives and progress of initiatives and projects
- Manages the planning and execution of team efforts, including all associated resources to meet committed delivery dates
**About you**
- 2+ years of experience in managing a team(s)
- 10+ years' experience in clinical research, including a minimum of 4+ years' of experience working in a role focused on quality management of clinical trials
- Well-versed in risked-based quality management (RBQM) and relevant ICH-GCP, US CFR, and HIPAA regulations
- Strong understanding of Quality Management Systems and CAPA process
- Possess experience in participating in audits and regulatory inspections. Ability to work with Quality Director in coordinating responses in relation to audit reports and analyzing audit findings
- Bachelor's degree or College degree in computer science, quality management, or any other related field
- Ability to work well with, and manage, a remote-based team
- Ability to excel in a fast-paced and rapidly changing environment.
- Possess strong attention to detail and problem-solving ability.
- Must be able to enforce and implement quality assurance and compliance standards.
- Possess excellent communication skills, be adaptable and patient.
- Ability to demonstrate good judgment and decision making, and personal accountability
Major pluses
- Start-up experience
- Quality certification from a recognized institution.
**About Curebase**
Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase's has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community.
This starts with Curebase's leading decentralized clinical trial software platform that is an all-in-one, purpose built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the "BYOP" or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials.
We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients' physical location. COVID-19 tailwinds have created massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide ado

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