TITLE:

Clinical Operations Manager
Title: Clinical Operations Manager
Reports To: Clinical Program Lead
Location: UK or US
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of OUD. Indivior is dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
POSITION SUMMARY: The Clinical Operations Manager is responsible for leading Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs) and clinical operations personnel in the oversight and management of clinical study operations needed to support medicine development projects. This role involves collaborating with Clinical Program Leads (CPLs) and Clinical Study Teams (CSTs) to integrate quality principles and appropriate risk-based approaches to clinical trial operations oversight. The Clinical Operations Manager establishes quality performance metrics and implements associated activities to ensure studies are conducted and reported according to applicable processes, procedures, and plans as well as applicable regulations and guidelines.
The core pillars of the Clinical Operations Manager’s role include overall eTMF, clinical monitoring, clinical trial support and study start up excellence.

MINIMUM QUALIFICATIONS:

• Education: Bachelor’s degree in a related field; advanced degree preferred.
• Experience: Proven experience in clinical operations management (8 years minimum), preferably in a pharmaceutical setting. Experience in site selection, activation and monitoring is a plus

The responsibilities of this role include, but are not limited to, the following:

Implementation and Management:

• Responsible for the implementation, management, and support of day-to-day clinical operations systems and associated processes. Systems include, but may not be limited to, eTMF, CTMS, and Clinical budgeting and forecasting tools. Manages completeness, archival, tracking and retrieval processes for completed eTMFs and legacy TMFs.
• Provides strategic leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality

Collaboration:

• Collaborates with members of Global Medicines Development (GMD) to ensure the continuing adequacy of clinical systems and support.
• Leads and manages the relationship with system-related vendors, ensuring appropriate contract scope, budgets, vendor performance and issue resolution.

Quality and Compliance:

• Collaborates with Clinical Quality, Process Excellence and Clinical Program Teams to ensure compliance to external regulations and internal policies.
• Acts as point of contact for SOP updates when applicable and ensures their team’s compliance with SOPs.
• Participates in inspection readiness activities and regulatory inspections.
• Oversees Clinical Operations reporting, metrics and KPIs.
• Develops and oversees global TMF-related standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., Trial Master File Reference Model).
• Develops, generates, analyzes and presents to Clinical Project Managers (CPMs), Clinical Study Teams (CSTs), and/or leadership standard metrics/KPIs to demonstrate the health of: TMF, clinical monitoring/clinical monitoring oversight, study start up and various trial support measures.

Team Coordination and Resource Management

• Oversees and coordinates all aspects of the clinical operations team.
• Organizes staff schedules, assigns duties and monitors performance.
• Ensures successful site activation and monitoring as well as efficient clinical trial administration and documentation.
• Monitors clinical systems’ budgets effectively.
• Responsible for maintaining appropriate contracts with vendors and negotiating rates and services when needed.
• Centrally manages Clinical Research Associate (CRA) and Clinical Trial Assistant (CTA) resources to ensure all clinical studies are supported according to timelines and priorities.

Training and Development:

• Provides training and development opportunities for clinical operations staff composed of Clinical Research Associates, Clinical Trial and eTMF Administrators