[Remote] Principal Scientist - Clinical Trials Manager

Note: The job is a remote job and is open to candidates in USA. Dechra is an international specialist veterinary pharmaceuticals products business focusing on high-quality products exclusively for veterinarians. The Principal Scientist (Clinical Trials Manager) will coordinate and oversee all aspects of clinical studies in support of global product registrations, ensuring compliance with scientific design and regulatory requirements.ResponsibilitiesAssist Efficacy Leads in designing clinical studiesDraft protocols together with the Efficacy Leads and Biostatistician and facilitate protocol review, submission for concurrence (if applicable), revision and finalizationCollaborate with Monitors to ensure appropriate clinical study site selection, qualification, and trainingSelection and coordination of central laboratory for clinical pathology and other external vendors, as applicableWork with Clinical Data Manager to ensure creation of a robust Electronic Data Capture database for clinical studiesCreate clinical study site budgets and approve study-related invoicesEstablish contracts with clinical sites and other vendorsWork with clinical supply coordinator to organize IVP/CP supply for studiesOversight of study monitoring in managed studies and review of key study data following site close-outsUpdate Efficacy Leads on study statusOversee data cleaning and database lockSupport Efficacy Leads in authorship of Final Study ReportsProvide technical and scientific support to members of the Product Development organization as neededWork with Clinical Operations personnel on the creation and implementation of policies and SOPs related to clinical studiesWork with Clinical Operations management to implement new processes and technologies related to study execution and oversightAssess resource needs for clinical studies and work with Clinical Operations management to determine appropriate allocation of internal and external resourcesProvide mentorship to other Clinical Trials ManagersRegular travel requiredSkillsCoordinate and oversee all aspects of clinical studies in support of global product registrationsEnsure studies are conducted in accordance with scientific design and timelines provided by the Efficacy LeadEnsure compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements/guidelines (e.g., Good Clinical Practice)Assist Efficacy Leads in designing clinical studiesDraft protocols together with the Efficacy Leads and Biostatistician and facilitate protocol review, submission for concurrence (if applicable), revision and finalizationCollaborate with Monitors to ensure appropriate clinical study site selection, qualification, and trainingSelection and coordination of central laboratory for clinical pathology and other external vendors, as applicableWork with Clinical Data Manager to ensure creation of a robust Electronic Data Capture database for clinical studiesCreate clinical study site budgets and approve study-related invoicesEstablish contracts with clinical sites and other vendorsWork with clinical supply coordinator to organize IVP/CP supply for studiesOversight of study monitoring in managed studies and review of key study data following site close-outsUpdate Efficacy Leads on study statusOversee data cleaning and database lockSupport Efficacy Leads in authorship of Final Study ReportsProvide technical and scientific support to members of the Product Development organization as neededWork with Clinical Operations personnel on the creation and implementation of policies and SOPs related to clinical studiesWork with Clinical Operations management to implement new processes and technologies related to study execution and oversightAssess resource needs for clinical studies and work with Clinical Operations management to determine appropriate allocation of internal and external resourcesProvide mentorship to other Clinical Trials ManagersAbility and willingness to travel nationally and internationally as requiredBenefitsFree weekly wellness sessions focused on our employee's physical and mental wellbeingFlexible work arrangementsGenerous employer 401k matchOther incentives for long-term financial wellnessFull array of health, financial and voluntary benefit programsCompany OverviewDechra is an international specialist veterinary pharmaceuticals and related products business. It was founded in 1997, and is headquartered in Northwich, Cheshire, GBR, with a workforce of 1001-5000 employees. Its website is http://www.dechra.com.