Senior Scientist - Clinical Trials

Vacancies

Senior Scientist - Clinical Trials

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 almost 3000 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

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 Senior Scientist, Clinical Trials is responsible for coordinating and overseeing all aspects of clinical supply logistics and data management for clinical and non-clinical studies conducted by Dechra Product Development. This role ensures the timely and compliant execution of study drug shipments, labeling, reconciliation, and data management activities, supporting the study teams throughout the project lifecycle.

Main Responsibilities

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

Clinical Supply

• Advise Product Development personnel on importation/exportation requirements for study drug/materials
• Draft necessary documents required for importing/exporting study drug and supplies for clinical and non-clinical studies, coordinate review and finalization of documents
• Work with Regulatory Affairs to ensure regulatory notifications for study drug shipments are submitted in a timely manner
• Coordinate shipments with appropriate couriers
• Collaborate with study teams on the content and finalization of the clinical supply plan (may include labelling, masking, logistics, etc.)
• Oversee labelling of study materials by CRO in accordance with the clinical supply plan
• Serve as main point of contact between Dechra personnel and relevant CROs, couriers, manufacturers, etc.
• Maintain relationships with suppliers, CROs, and couriers and ensure that necessary contracts are kept up to date

Data Management

• Manage electronic data capture system and database for clinical including programming of rules and edit-checks to facilitate monitoring of study data
• Function as both the administrator and "super user" of the electronic data capture (EDC) software for clinical trials
• Develop Case Report Forms, electronic and/or paper
• Conduct database validation and user acceptance testing
• Write and implement Data Management Plan for clinical trials
• Work with team to provide data for status updates, metrics, and reports
• QC of data, tables, and reports as needed by team
• Ensure the quality of study data prior to conducting database lock
• Provide team with study data for final study reports (tables/listings)
• Coordinate archiving of the database
• Assist with evaluation of new software platforms to determine best option given needs of the team

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:

• Demonstrated understanding of study design, database programming, and study logistics
• Strong analytical and organizational skills with the ability to handle multiple tasks and prioritize
• Effective communication with excellent written and verbal skills
• Minimum one year of experience in data management and/or clinical supply management of clinical studies

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 and 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 .