Lead Clinical Data Manager

Elanco Innovation And Alliance Centre; Bengaluru; Hybrid; INR 2,400,000 - 4,200,000; Full time

Job summary

Elanco Innovation And Alliance Centre in Bengaluru, India seeks a Senior Lead Data Manager with 8+ years in Clinical Data Management to lead end-to-end data management activities within R&D projects.

You will drive study setup, execution, and close-out, ensure regulatory compliance, manage dashboards, and collaborate across internal teams and external partners to deliver high-quality data solutions.

Qualifications

• Minimum 8 years of experience in Clinical Data Management.

Responsibilities

• Proactively search for solutions.
• Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve Elanco R&D deliverables.
• Create a positive work environment aligned with company objectives.
• Provide and accept challenge 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 objectives in a high-quality, timely, cost-effective manner.
• Demonstrate adaptability, flexibility, and learning agility.
• End-to-End Clinical Data management.
• Experience in study set-up, conduct, and close-out activities including protocol review, eCRF specification writing, CRF UAT, Edit check specification, Database lock, and cross-functional stakeholder management.
• Support deployment, validation, testing and implementation of electronic data capture systems as part of data management strategies.
• Support preparation and implementation of study data management plans across R&D project teams from initiation to completion.
• Ensure adherence to clinical data collection policies and procedures and keep Elanco at the forefront of standards for the animal health industry.
• Confirm validation and compliance with all regulations (including GxP) and guidelines for the global data management systems and processes utilized to collect, manage, report, store, and archive databases containing clinical data.
• Be part of regular connects with site lead and study team (Site/Study program leads).
• Support/Monitor the UAT activities on the studies assigned
• Perform/Monitor the archival activities.
• Provide the necessary support on creating/updating the study-specific documents as needed.
• Update all the dashboards for metrics generation
• Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
• Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
• Lead innovation and collaborate with other function leads for process refinement and introduction of new process optimization tools.
• Engage in knowledge-sharing activities.

Job description

Role & responsibilities

Functions, Duties, Tasks:

Key Leadership 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 challenge 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

Key Technical Responsibilities

• End-to-End Clinical Data management.
• Experience in study set-up, conduct, and close-out activities including protocol review, eCRF specification writing, CRF UAT, Edit check specification, Database lock, and cross-functional stakeholder management.
• Support deployment, validation, testing and implementation of electronic data capture systems as part of data management strategies.
• Support preparation and implementation of study data management plans across R&D project teams from initiation to completion.
• Ensure adherence to clinical data collection policies and procedures and keep Elanco at the forefront of standards for the animal health industry.
• Confirm validation and compliance with all regulations (including GxP) and guidelines for the global data management systems and processes utilized to collect, manage, report, store, and archive databases containing clinical data
• Be part of the regular connects with site lead and study team (Site/Study program leads).
• Support/Monitor the UAT activities on the studies assigned
• Perform/Monitor the archival activities.
• Provide the necessary support on creating/updating the study-specific documents as needed.
• Update all the dashboards for metrics generation
• Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
• Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
• Lead innovation and collaborate with other function leads for process refinement and introduction of new process optimization tools.
• Engage in knowledge-sharing activities.

Preferred candidate profile

Minimum 8 years of experience in Clinical Data Management

JD Link: https://elanco.wd5.myworkdayjobs.com/en-US/External_Career/job/Senior-Lead-Data-Manager_R0026789-2