Study Monitor

2 weeks ago

Northwich, United Kingdom Dechra Full time

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of over 2000 colleagues globally. From manufacturing to marketing, ( D )edication, ( E )njoyment, ( C )ourage, ( H )onesty, ( R )elationships and ( A )mbition are at the heart of our everyday operations and the way we do business.

The Opportunity 

The primary function of the Study Monitor position is to participate in monitoring activities for clinical and non-clinical studies conducted by the Dechra Clinical Operations Team. The Study Monitor will work with the Clinical Trials Manager or Non-Clinical Studies Manager to ensure that studies are conducted in accordance with the scientific design and timelines provided by the Efficacy Technical Lead and in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements/guidelines (e.g., Good Clinical Practice). The Study Monitor will act as the point of contact for their designated clinical study sites and provide regular updates to the Clinical Trial Manager/Non-clinical Studies Manager.

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:

Monitoring

Monitor study sites including activities associated with study initiation, execution, close-out, and submission Assist with site selection and evaluation Serve as point of contact between Dechra and study sites

Study Coordination

Assist the Clinical Trials Manager or Non-Clinical Studies Manager with study activities including but not limited to review of draft protocols, site budgets and invoicing, monitoring tools Serve as point of contact for new clinical study sites Provide oversight of study master files (electronic and paper) and preparation of the study files for archiving/submission Assist Clinical Trials Manager or Non-Clinical Studies as needed

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 Participate in database cleaning following site close-outs and assist with database lock Assist with review and QC of 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:

Animal Health experience required  Experience in monitoring/participating in veterinary clinical field trials College degree in relevant field preferred  Demonstrated understanding of protocols, data collection methodologies, GCP guidelines, and report writing  Strong analytical & organizational skills with the ability to handle multiple tasks and prioritize  Ability to communicate effectively with excellent written/verbal skills

Please note: Regular travel is required 

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