Manager, Study Training Compliance – DOA Matrix Management

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November 20

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CARE

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Healthcare Insurance • Education • Recruitment

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

5001 - 10000 employees

Founded 1945

⚕️ Healthcare Insurance

📚 Education

🎯 Recruiter

💰 Grant on 2021-11

📋 Description

• Supervise, mentor, and develop a team of specialists and senior specialists supporting study training compliance and DOA matrix functions. • Manage daily team operations including task delegation, performance tracking, workload balancing, and professional development support. • Establish team goals, timelines, and KPIs aligned with departmental and organizational priorities. • Ensure team adherence to SOPs, training protocols, and documentation standards. • Oversee organization-wide monitoring of clinical staff training completion for both study-specific and mandatory compliance training. • Ensure standardization of training tracking workflows, documentation accuracy, and timely resolution of gaps across trials. • Collaborate with internal clinical education team, compliance, and operations teams to align on training expectations and rollout strategies. • Own the process for DOA matrix setup, maintenance, review, and investigator approvals across trials. • Ensure delegation alignment with role-based training completion, protocol requirements, and site activation timelines. • Serve as a subject matter expert on DOA matrix processes during audits, inspections, and sponsor inquiries. • Partner with Clinical Operations, Quality, Clinical Education, and other internal stakeholders to ensure training and delegation matrix readiness across study lifecycles. • Support site-staff and study start-up readiness by contributing to training plans, documentation checklists, and process guidance. • Represent the function in planning meetings, trial kick-offs, and sponsor-facing communications when required. • Develop and refine audit preparedness strategies across Central Support Operations. • Identify gaps, inefficiencies, and risks in current workflows; lead improvement initiatives to increase compliance, efficiency, and documentation integrity. • Contribute to the development and refinement of SOPs, Work Instructions, system design, and quality tools to support scale and consistency across programs. • Monitor performance metrics and provide insights to leadership to support continuous improvement. • Perform other duties as assigned.

🎯 Requirements

• Deep understanding of clinical research operations, GCP compliance, and site readiness requirements. • Strong leadership and team development skills, with the ability to guide staff through complex compliance and operational workflows. • Advanced skills in documentation management, audit preparation, and protocol compliance tracking. • Proficiency with systems such as Florence (eISF), Clinical Conductor (CTMS), and sponsor-facing training platforms. • Excellent interpersonal and communication skills, including the ability to interact professionally with clinical teams, sponsors, and leadership. • Strong analytical and organizational abilities with attention to documentation accuracy, timelines, and regulatory requirements. • Proficient in Microsoft Office Suite and collaborative tools (Excel, SharePoint, Outlook, etc.). • Bachelor’s degree in Life Sciences, Health Administration, Clinical Research, or a related field required; Master’s degree or certification (e.g., ACRP, SOCRA) preferred. • Minimum of 5+ years of experience in clinical research or regulatory compliance, including at least 2 years in a team lead or management role. • Demonstrated success in managing training compliance, DOA matrix workflows, and documentation oversight within a regulated clinical trial environment. • Experience supporting audits, inspection readiness, and cross-functional collaboration in a multi-study organization.

🏖️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays • 100% Employer paid medical, dental, and vision insurance plan options • Health Savings Account and Flexible Spending Accounts • Bi-weekly HSA employer contribution • Company paid Short-Term Disability and Long-Term Disability • 401(k) Retirement Plan, with Company Match