Senior Clinical Study Monitor

Vacancies

Senior Clinical Study Monitor

Job Introduction

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 Opportunity

The primary function of the Scientist, CRA (Senior Study Monitor) position is to lead monitoring activities for clinical conducted by the Dechra Clinical Operations Team. The Senior Study Monitor will work with the Clinical Trials Managers to ensure that studies are conducted in accordance with the scientific design and timelines provided by the Efficacy Leads and in compliance with protocol and applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements/guidelines (e.g., Good Clinical Practice). The Senior Study Monitor will act as the point of contact for the clinical study sites and Monitors and provide regular updates to the Clinical Trial Managers and Efficacy Leads. The Senior Study Monitor will also ensure that there is consistency in monitoring across study sites and between monitors.

Role Responsibility

So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:

• Act as the lead monitor and mentor Monitors in all aspects of study monitoring to ensure consistency in monitoring practices and ensure high quality compliant study data.
• Monitor study sites and lead monitoring activities associated with study initiation, execution, close-out, and submission.
• Coordinate site selection and evaluation.
• Serve as point of contact between Dechra and study sites and Monitors.
• Collaborate with the Clinical Trials Managers in the management of studies including creation of draft protocols, leading clinical study team meetings, site budgets and invoicing, clinical supply plans, and updates to the Efficacy Leads
• Oversight of study master files (electronic and paper) and preparation of the study files for archiving/submission.
• Oversight of data quality from Monitors.

Data management support

• Ensure robust Electronic Data Capture database is present for studies with optimized edit checks to facilitate monitoring of data.
• Provide guidance to data entry and QC personnel to ensure a high-quality database and resolution of discrepancies.
• Oversee database cleaning following site close-outs and assist with database lock.
• Provide input for data tables, and reports as needed by team

The Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:

• Strong analytical & organizational skills with the ability to handle multiple tasks and prioritize.
• Ability to communicate effectively with excellent written/verbal skills.
  Understanding of protocols, data collection methodologies, GCP guidelines/FDA GLP 21 CFR58, and report writing.
• Significant experience monitoring veterinary clinical field trials in support of submissions targeted toward FDA-CVM, USDA, and/or European regulatory authorities

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.