Senior Data Manager

Roche • Indianapolis, IN

1d • Onsite

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Senior Data Manager The Sr. Data Manager (DM) is responsible for the development, execution and oversight of all data management plans, deliverables, and processes on assigned projects. The DM serves as the subject matter expert and primary interface between global Study Teams and Biostatistics groups, local study teams and/or CRO’s relative to all data within specific studies, databases, and/or electronic data capture (e-DC) and case report form (e-CRF) applications and systems. The DM leads and oversees data management activities including CRF and database development based on study protocols and needs, periodic data quality checks, data queries, data cleaning and discrepancy management. Coordinates the formatting and storage of study data per study protocol, SOP, area work instructions and post-production change management to maintain high quality data records. This opportunity is based in Indianapolis, IN, on-site (3 days per week approximately). The Opportunity The DM works with Study Managers and Clinical Research Associates to provide both in-house and on-site user training and secondary user support, as required on individual studies. The DM supports Quality and Regulatory compliance initiatives on all projects, and handles the coordination of change requests during the life-cycle of study data handling tools. Specialized and in-depth comprehensive knowledge and experience in a particular field, or business area. Duties are varied and complex, often involving research, analysis and solution development. Provides direction on issues of area of expertise and assist department leadership in setting strategic direction. Requires the regular use of originality and ingenuity. Plans, conducts and oversees work involving the largest and most important/complex projects. Does not supervise, but provides direction to team on projects and assignments. Works with minimum supervision. Reviews progress with management. Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Requirements

• Bachelor’s degree in life science/Laboratory, computer science or related field
• 1-2 years’ experience in data management and analysis, study management and reporting of clinical study results
• Experience in database design, construction and verification/validation
• Demonstrated leadership skills in coordinating data workflow within clinical studies
• Ability to work in an efficient and collaborative fashion with multi-disciplinary teams
• Strong communication and interpersonal skills

Responsibilities

• Guides and advises study teams on the definition of the data management and the study management in the paper and/or electronic systems.
• Reviews protocol on clinical/technical data management and system implications.
• Creates clinical data management plan.
• Collaborates globally as needed on the design, documentation, testing and implementation of clinical data studies.
• Ensures the use of standards and alignment of data management when supporting studies.
• Uses tools and provides guidance in order to execute timely data reconciliation, data cleaning, and data analysis.
• Responsible for timely delivery of clean, complete high quality data for analysis.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees