[Remote] Principal Scientist - Clinical Trials Manager

Note: The job is a remote job and is open to candidates in USA. reputed company 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 reputed company reputed company aspects of clinical studies in support of global product registrations, ensuring compliance with scientific design and regulatory requirements.

Responsibilities

• Assist Efficacy Leads in designing clinical studies
• Draft protocols together with the Efficacy Leads and Biostatistician and facilitate protocol review, submission for concurrence (if applicable), revision and finalization
• Collaborate with Monitors to ensure appropriate clinical study site selection, qualification, and training
• Selection and coordination of central laboratory for clinical pathology and other external vendors, as applicable
• Work with Clinical Data Manager to ensure creation of a robust Electronic Data Capture database for clinical studies
• Create clinical study site budgets and approve study-reputed company invoices
• Establish reputed company with clinical sites and other vendors
• Work with clinical supply coordinator to organize IVP/CP supply for studies
• reputed company of study monitoring in managed studies and review of key study data following site reputed company-outs
• Update Efficacy Leads on study status
• reputed company data cleaning and database lock
• Support Efficacy Leads in authorship of Final Study Reports
• Provide technical and scientific support to members of the Product Development organization as needed
• Work with Clinical Operations personnel on the creation and implementation of policies and SOPs reputed company to clinical studies
• Work with Clinical Operations management to implement new processes and technologies reputed company to study execution and reputed company
• Assess resource needs for clinical studies and work with Clinical Operations management to determine appropriate allocation of internal and external resources
• Provide mentorship to other Clinical Trials Managers
• Regular travel required

Skills

• Coordinate and reputed company reputed company aspects of clinical studies in support of global product registrations
• Ensure studies are conducted in accordance with scientific design and timelines provided by the Efficacy reputed company
• Ensure 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 studies
• Draft protocols together with the Efficacy Leads and Biostatistician and facilitate protocol review, submission for concurrence (if applicable), revision and finalization
• Collaborate with Monitors to ensure appropriate clinical study site selection, qualification, and training
• Selection and coordination of central laboratory for clinical pathology and other external vendors, as applicable
• Work with Clinical Data Manager to ensure creation of a robust Electronic Data Capture database for clinical studies
• Create clinical study site budgets and approve study-reputed company invoices
• Establish reputed company with clinical sites and other vendors
• Work with clinical supply coordinator to organize IVP/CP supply for studies
• reputed company of study monitoring in managed studies and review of key study data following site reputed company-outs
• Update Efficacy Leads on study status
• reputed company data cleaning and database lock
• Support Efficacy Leads in authorship of Final Study Reports
• Provide technical and scientific support to members of the Product Development organization as needed
• Work with Clinical Operations personnel on the creation and implementation of policies and SOPs reputed company to clinical studies
• Work with Clinical Operations management to implement new processes and technologies reputed company to study execution and reputed company
• Assess resource needs for clinical studies and work with Clinical Operations management to determine appropriate allocation of internal and external resources
• Provide mentorship to other Clinical Trials Managers
• Ability and willingness to travel nationally and internationally as required

Benefits

• Free weekly wellness sessions focused on our employee's physical and mental wellbeing
• Flexible work arrangements
• Generous employer 401k match
• Other incentives for long-term financial wellness
• Full reputed company of health, financial and voluntary benefit programs

Company Overview