Principal Scientist, Clinical Trials Manager

Principal Scientist, Clinical Trials Manager

Job Introduction

Job Purpose

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high-quality products exclusively for veterinarians worldwide.

The primary function of the Principal Scientist (Clinical Trials Manager) position is to coordinate and oversee all aspects of Dechra's clinical studies in support of global product registrations. The Principal Scientist, Clinical Trials Manager will ensure that studies are conducted in accordance with the scientific design and timelines provided by the Efficacy Lead and are in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements/guidelines (e.g., Good Clinical Practice). The Principal Scientist, Clinical Trials Manager is supported by internal Study Monitors, Clinical Data Managers, and administrative staff along with external contract resources as needed.

Key Responsibilities

• Assist Efficacy Leads in designing clinical studies
• Draft protocols together with the Efficacy Leads and Biostatistician and facilitate protocol review, submission for concurrence (if applicable), revision and finalization.
• Collaborate with Monitors to ensure appropriate clinical study site selection, qualification, and training
• Selection and coordination of central laboratory for clinical pathology and other external vendors, as applicable
• Work with Clinical Data Manager to ensure creation of a robust Electronic Data Capture database for clinical studies
• Create clinical study site budgets and approve study-related invoices
• Establish contracts with clinical sites and other vendors
• Work with clinical supply coordinator to organize IVP/CP supply for studies
• Oversight of study monitoring in managed studies and review of key study data following site close-outs
• Update Efficacy Leads on study status
• Oversee data cleaning and database lock
• Support Efficacy Leads in authorship of Final Study Reports
• Provide technical and scientific support to members of the Product Development organization as needed
• Work with Clinical Operations personnel on the creation and implementation of policies and SOPs related to clinical studies
• Work with Clinical Operations management to implement new processes and technologies related to study execution and oversight
• Assess resource needs for clinical studies and work with Clinical Operations management to determine appropriate allocation of internal and external resources
• Provide mentorship to other Clinical Trials Managers
• Regular travel required

Key Performance Indicators

• Meeting project-specific timelines and enrolment targets
• Excellent data integrity/quality as evidenced by study audits and FDA inspections/reviews
• Clear and effective communication
• Adaptable to challenges within the study and handling them appropriately
• Appropriate escalation of concerns
• Minimizing time from Last Patient Out to Database Lock