Instat provides comprehensive data management and statistical services for all phases of clinical development. Our data managers, statisticians and statistical programmers offer unique skill and experience to our clients. We are a small group of experts who focus on the client relationship, and we do excellent work. We love what we do!

At Instat, we work on exciting projects.  We challenge our employees to be involved in all tasks of a project using the best technology.  We have fun and always deliver the best possible quality to our clients. We think you'll enjoy working with us too.

This position is responsible for successfully leading the execution of all data management activities for assigned projects, ensuring focus on data integrity, validity, reliability in accordance with standard processes, the sponsor guidelines, industry best practices and regulatory standards.  This position may be involved in process improvement initiatives to support the department and company in achieving objectives and strategic goals.  Essential duties and responsibilities include:

Lead all data management activities from study start-up through final database lock, including but not limited to:

• Creating and tracking timelines for Data Management activities
• Creation and maintenance of the Data Management Plan
• Development and design of Case Report Forms (CRFs)
• Development of Database Build specifications
• Database Build and testing activities 
• Defining, building and testing edit checks
• Performing data review and query generation/resolution
• Processing/reconciling electronic data received from other data sources, Safety database, labs, IRT
• Database lock and transfer process
• Track project progress and issue status reports to ensure the achievement of key Data Management milestones, such as database Go-Live and completion of tasks towards Database Lock.
• Coordinate the work of global staff assigned to the project.
• Lead and/or participate in internal and sponsor meetings as required, working directly with the sponsor and other internal functional leads to 
• Ensure approved study documentation is maintained and properly stored in the trial master files
• Develop or assist with the project training development and delivery, for investigators, clinical sites, project teams and sponsors on data collection processes, tools and/or equipment as required
• Act as point of escalation for data related issues and queries
• Contribute to the continuous improvement of DM and the wider organization through information sharing, training and education
• Promote and be an advocate of DM internally and externally
• Coach, mentor and/or train peers, contribute to peer selection, performance evaluation, peer orientation and project communications 
• May lead or participate in the development, review and implementation of processes, policies, SOPs/WI’s and associated documents affecting DM
• May participate in and/or lead DM and cross functional working groups
• May represent the department at Business Development related meetings

The Senior Data Manager will have a Bachelor’s Degree or RN with five (5) years’ experience in clinical research, drug development, or other healthcare environment, including three (3) years’ experience in data management.

• This position is home-based, but may include onsite assignments with clients.
• All applicant information will be kept confidential according to EEO guidelines.