Consultant- Clinical Operations

Role Summary

The Consultant Clinical Operations leads global clinical data management objectives, leveraging systems and processes used during data capture, management, reporting, storage and archival. The role may involve electronic data and may include paper data collection processes and systems. This leadership position is expected to be highly influential in partnering with product development teams, internal sites, and third parties to develop data management strategies that result in on-target delivery of final databases. This position will closely collaborate with R&D functions including clinical development, internal study sites, biostatistics, regulatory affairs, and quality assurance to ensure data integrity, data quality, validation, and compliance. This position will also provide leadership and management of DM activities for clinical projects and internal sites.

Responsibilities

• Proactively search for solutions.
• Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve overall Elanco R&D deliverables.
• Create a positive work environment that is aligned with company objectives.
• Provide and accept challenges to deliver innovative technical solutions and create an innovative culture.
• Create an engaging culture with a "Play to Win" mentality.
• Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner.
• Demonstrate high levels of adaptability, flexibility, and learning agility
• Educate, represent, and advocate for DM policies and procedures with internal and external stakeholders
• Coach and mentor DM colleagues, contribute to their knowledge of the animal drug development field.
• Provide expertise in deployment, validation, testing and implementation of electronic data capture systems as part of data management strategies
• Responsible for preparation and implementation of study data management plans across R&D project teams from initiation to completion
• Coordinate resources and capabilities both internally and externally to achieve R&D target objectives.
• Ensure adherence to clinical data collection policies and procedures and is expected to keep Elanco at the forefront of standards for the animal health industry
• Train and educate R&D functions, including project teams, biostatistics, regulatory affairs and quality assurance on data collection systems, processes, and best practices
• Confirm validation and compliance to all regulations (including GxP), guidelines, global data management systems, and process utilized to collect, manage, report, store and archive databases containing clinical data
• Maintain DM project timelines, assure they are met
• Site/project level interactions and rapport building with all key stakeholders.
• Review and monitor the workload including forecast at the site/project level.
• Point of contact (POC) for all the DM activities for the assigned site/project
• Drive standardization at the site/project and department level
• Author as appropriate, review and provide inputs to all the data management documents (DMP, Project plan, UAT log, EFPs, Training Documents, etc)
• Facilitate communication to Global DM team members as appropriate (may lead to regular team meetings including the Lead DM)
• Function as liaison for sites/project teams, represent and address their needs within DM general business processes
• Additional responsibilities as assigned

Qualifications

• Required: BS or equivalent in IT, statistics or scientific field related to animal health, or relevant work experience in the animal drug development industry
• Required: 10 or more years of experience working in a global network or supporting a global network, specifically in animal health R&D
• Required: Thorough knowledge of electronic systems and capabilities and their application in animal/ health R&D, maintenance validation and data pulls are a plus
• Required: Demonstrated leadership skills and ability to work within and across interdisciplinary teams
• Preferred: Clinical trial experience and/or clinical trial data experience
• Preferred: Advanced knowledge of electronic data capture systems
• Preferred: Experience interacting with regulatory authorities and regulatory submissions
• Preferred: Project Management and/or development of QMS experience

Additional Requirements

• Travel: 0%
• Location: India, Bangalore