Principal Scientist – Clinical Trials (EU)
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.
We are 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.
This role can be performed remotely in any European Dechra entity.
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 primary function of the Principal Scientist, EU Clinical Trials is to fulfil the role of Clinical Trials Manager on European and international clinical field trials sponsored by both Dechra Product Development and Invetx. They will coordinate and oversee the outsourcing of study conduct to various European CROs to ensure that studies are conducted in accordance with the scientific design and timelines provided by the Sponsor Representative and are in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements/guidelines (e.g., Good Clinical Practice).
Main Responsibilities
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Collaborate with the Sponsor Representative in designing operational aspects of clinical studies and selection of appropriate CRO.
- Draft protocols together with the Sponsor Representative and Biostatistician and facilitate protocol review, revision, and finalization
- Supervise CRO Monitors and other staff to ensure appropriate clinical study site selection, qualification, and training
- Work with Clinical Supply group to organize IVP/CP supply for studies.
- Selection and coordination of central laboratory for clinical pathology and other external vendors, as applicable
- Ensure, in collaboration with Clinical Data Manager, creation of a robust Electronic Data Capture database for clinical studies
- Collaborate with CRO to ensure clinical study site budgets are created and may approve study-related invoices
- Collaborate with CRO to establish contracts with clinical sites and other vendors
- Oversight of study monitoring and ensure additional review conducted for key study data following site close-outs
- Update Sponsor Representative on study status
- Oversee data cleaning and database lock
- Work with Clinical Operations management to implement new processes and technologies related to study execution and oversight
- May act as Monitor for clinical study sites on an as-needed basis
- Regular travel required
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 keen 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.
- Demonstrated understanding of protocols, data collection methodologies, GCP guidelines, and report writing.
- Significant experience in management and monitoring of veterinary clinical studies in companion animals
All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at recruituk@dechra.com
