eCOA Quality Event & CAPA Manager

Clinical ink; Mississippi; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading clinical technology firm is seeking an eCOA Quality Event & CAPA Manager to enhance compliance and quality practices. This remote position requires a bachelor's degree and at least 5 years in eCOA delivery. The ideal candidate possesses strong analytical abilities and communication skills, ensuring adherence to quality standards and overseeing critical compliance processes. Join us in shaping the future of clinical trials.

Benefits

Robust benefits (medical, dental, vision, financial)

Unlimited vacation

Education assistance

Parental leave

Qualifications

• Minimum of 5 years of experience working in eCOA delivery organizations.
• Strong knowledge of quality management principles, standards, and regulatory requirements.
• Knowledge of FDA Quality System and Global Regulations preferred.

Responsibilities

• Manage and oversee Quality Event (QE) and CAPA processes.
• Assist stakeholders in structured problem-solving methodologies.
• Maintain and update standard operating procedures (SOPs).
• Support internal and external audits.

Skills

Excellent communication skills

Cross-functional teamwork

Analytical and problem-solving skills

Attention to detail

Knowledge of quality management principles

Education

Bachelor’s degree or relevant experience

Tools

Quality management software

Lean Six Sigma

MasterControl

Job description

Overview

We're on a Mission to Advance Clinical Discovery. Patients are our ultimate why, and pioneering technology for patient outcomes is our DNA.

Join us to advance the life sciences industry with technology solutions that transform the clinical trial experience for patients and put our research clients on the path to making confident, better-informed decisions, faster.

When you join the Clinical ink team, you enjoy:

• Robust benefits (medical, dental, vision, financial)
• Unlimited vacation
• Education assistance
• Parental leave

View our Job Openings!

Position: eCOA Quality Event & CAPA Manager

Location: Remote

Job Id: 591

# of Openings: 1

Company Information

Clinical ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in Philadelphia, PA, Winston Salem, NC, and Iowa City, IA. Clinical ink is rewriting the clinical development experience.

Job Description

Clinical ink is seeking an eCOA Quality Event & CAPA Manager to join our Compliance team based remotely across the United States. This individual will oversee the quality event and CAPA process, ensuring compliance with internal procedures and regulations. This position will support a strong culture of quality and accountability within the organization, and will work cross-functionally to ensure all compliance-related activities are completed for quality events and CAPAs. The eCOA Quality Event & CAPA Manager's responsibilities include:

• Manage and oversee Quality Event (QE) and Corrective and Preventative Action (CAPA) processes, and ensure adherence to internal SOPs, WIs, policies and regulatory requirements
• Assist key stakeholders, Action Owners (AOs), and functional teams in the application of structured problem-solving methodologies, root cause analysis (RCA), investigations, and related actions
  • Work with stakeholders to identify resources to support RCA, investigation, and associated actions
  • Ensure all process requirements and actions are completed
• Coach and advise stakeholders and AOs to ensure clear understanding of their roles and responsibilities in the CAPA process
• Serve as the subject matter expert for the quality event management system that is housed in the eQMS
• Maintain and update standard operating procedures (SOPs) related to quality events and CAPAs
• Manage QE and CAPA deliverables and timelines by communicating due dates and escalating potential issues to management if needed
• Liaise between the Compliance/Quality team and key stakeholders to ensure all QE and CAPA related activities are completed
• Assist with Compliance and Quality operations by:
  • Driving a company culture of quality and accountability
  • Working with stakeholders to create, update, and maintain process documentation in the quality management system
  • Supporting internal and external audits
  • Implementing quality and regulatory policies and procedures that align with and support business goals and objectives
  • Working with Human Resources and functional leaders to ensure proper employee and contractor training assignments are reflected on the training matrix and maintained in the eQMS
• Complete other tasks, activities, and/or special projects as assigned

Qualifications

• Bachelor’s degree or relevant equivalent experience in project management, clinical operations, or related field
• Minimum of 5 years of experience working in eCOA delivery organizations
• Excellent written and verbal communication skills; the ability to communicate with various levels of internal and external personnel
• Demonstrated ability to work cross-functionally and enhance organizational understanding of compliance and quality standards
• Strong knowledge of quality management principles, standards, and regulatory requirements
• Excellent analytical and problem-solving skills; strong attention to detail with a focus on accuracy and precision
• Knowledge of Lean Six Sigma or other process improvement methodologies
• Experience with quality management software and tools (MasterControl experience preferred)
• Knowledge of FDA Quality System and Global Regulations preferred

Additional Information

Clinical ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.

www.clinicalink.com

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Direct 1.336.464.0697