Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Manager of Data Management, located in Cincinnati, OH, Redwood City, CA, Santa Clara, CA or Raritan, NJ.
Robotics and Digital Solutions, is part of Johnson & Johnson Med Tech. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara) and Cincinnati. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes.
Overall Responsibilities:
The Manager, Data Management (DM) reports to the Director, Biostatistics and Data Management and is responsible for the oversight, growth, and development of Clinical Data Management (CDM) associates and for executing and overseeing CDM operational activities, ensuring compliance with protocols, timelines, good clinical practice, and regulations (US & EU). The Manager, DM will be looked upon to standardize processes and implement best practices in an effort to improve quality and streamline data collection/validation efforts. They will demonstrate a comprehensive knowledge of database applications, data management best practices and industry standards to strategically approach delivery of data management services. In addition, contribute broadly to DM functional initiatives, and actively participate in the development, implementation, and management of data collection ensuring its highest quality and integrity. Oversee work of data management services which are outsourced to data management partners, EDC, randomization, and imaging vendors in addition to data provided by core labs.
Key Responsibilities:
- Oversee and manage DM related activities (which may be outsourced to DM Vendors) as well as other external data sources from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget.
- Responsible for hiring, training, and retaining a diverse group of CDM personnel. Accountable for the development of direct reports through performance reviews, instruction, mentoring and coaching. This includes setting goals, conducting periodic and year end performance reviews, proactively identifying and addressing any areas of concern, providing development opportunities to team members and as needed, and escalating performance and/or personnel issues.
- Ensuring adherence to pertinent regulations through regular review of EDC system metrics and communications with cross functional stakeholders.
- Represent Data Management and actively participate on Clinical Study Core Team meetings for all study activities.
- Lead/Drive the development and implementation of data management standard working practices along with preparations and requirements for regulatory inspections and or submissions.
- Lead/Drive initiatives aimed at standardizing best practice including the development of standard CRFs, SOP/WI development, and various process related documentation to drive quality and efficiency.
- Coordinate and participate in the development of the clinical database design according to protocol requirements and study specifications.
- Manages service providers (CROs) independently on data management activities and maintains a good working relationship with vendor. Escalates issues as needed to Director.
- Assists with departmental budget development and management.
- Responsible for vendor performance, deliverables, and key measures.
- Reviews vendor proposals and contracts for inclusion of appropriate scope of work, pricing and agreed services.
- Develop and test data management system edit/data validation checks and special listings/procedures used as tools for the data review and discrepancy management activities.
- Authors, reviews/revises DM related study plans and other study documents to ensure quality and standardization.
- Review study data for completeness and clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations.
- Responsible for integration of clinical trial related data across diverse internal/external systems, data providers, and data file types.
- Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.
- Lead efforts coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed.
- Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner.
- Constructively challenges process and assumptions to cultivate development and implementation of refined solutions.
- Provides feedback on process, execution and performance to foster continuous learning and growth of self and team.
- Applies strategic thinking to lead, plan and execute the delivery of data management services and formulate innovative ideas.
- Understands and examines the implications of cross functional decisions and the potential downstream effects on data quality and integrity.
- Maintains accurate and complete study records.
- Ability to perform additional responsibilities as requested.
The anticipated base pay range for this position is $115,000 to $190,000. For candidates in the San Francisco Bay area ONLY – $130,000 to $220,000.