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Roche

(Associate) Manager, Data Management

Principle Roles & Responsibilities / Accountabilities
Performs tasks described in previous job level and additional tasks as specified below:

  • Leads the Clinical Data Management (CDM) study team and maintains oversight of all study activities
  • Manages lab reference ranges and processes
  • Participates in the oversight and prioritization of work for data managers
  • Is responsible for all deliverables for the sub function for one or more studies
  • Provides input during protocol review to ensure PDM components are included and comprehensive
  • Identifies business and technical risks and proposes mitigation strategies
  • Communicates study timelines and deliverables to all CDM study team staff and follows up to ensure timely delivery of assigned tasks
  • Effectively communicates ideas, project goals and status of work
  • Is accountable for delivery of quality data for project milestones, decision analysis and database locks
  • Partners with SMT in the collection and resolution of data issues at the study level
  • Is accountable for creation and maintenance of CDM study documentation in line with the protocol requirements
  • Contributes to Program Data Management (PDM) timelines and risk management at the study level
  • Identifies issues and data trends and takes corrective action to resolve
  • Coordinates user acceptance testing for clinical database
  • Provides PDM study specific training to CDM staff, including service providers
  • Actively participates in study debrief meetings, shares learnings with CDM staff and participates in subsequent best practice implementation
  • Participates in Service Provider selection, evaluation and management, including reviewing and providing input to scope of work (SOW)
  • Creates study-specific work orders and manages the handover of PDM tasks to service providers
  • Provides guidance and support to service provider on study-level PDM tasks
  • Reviews and monitors the study-level PDM tasks performed by the service provider, as needed
  • Reviews and approves study documentation, presentations and other deliverables produced by service providers
  • Acts as PDM primary contact with service provider
  • Prepares PDM materials and presents at investigator/coordinator meetings
  • Contributes to local and sub functional working groups and initiatives
  • Participates in the local functional/cross-functional implement-tation of best practices and process improvement initiatives
  • Performs discrepancy management for automated and manual queries
  • Performs entry of lab reference ranges and assignment of ranges to patients
  • Performs user acceptance testing for the clinical databases
  • Performs data management activities in preparation for snapshots, interim analysis and database closures
  • Performs reconciliation of data, where appropriate
  • Effectively communicates status of work
  • Knows targeted timeframes for deliverables and seeks guidance when time-frames may not be met
  • Is responsible for archival of study documentation
  • Contributes to local working groups
  • Performs additional tasks as needed

Qualification and Experience
Education/Qualifications

  • BA/BS degree or equivalent and entry-level working experience
  • Knowledgeable of theories and principles and how to apply them within his or her discipline/sub function
  • Full understanding of the business of his or her sub function

Job Required Competencies

  • Ability to work under guidance with general instructions on new assignments
  • Understanding and adherence to all applicable ICH and corporate GCP regulations and SOPs
  • Proficiency in technical applications
  • Understanding and utilization of company data collection standards, CDM processes, procedures and guidelines with respect to fit-for-purpose
  • Knowledge of CDM applications
  • Prioritization and management of tasks
  • Ability to work well with others
  • Organizational skills
  • Problem-solving skills
  • Project management skills
  • Conflict management skills
  • Written and verbal communication skills, including presentation skills
  • Knowledge of CDM’s role in drug development
  • Functional knowledge in a specific area
  • Ability to apply existing and developing technical skills to complete assignments and tasks
  • Ability to proactively monitor resource needs to ensure that deliverables and timelines are met
  • Contribution to the awareness and education of colleagues by knowledge sharing within the sub function
  • Ability to represent at industry user groups and conferences
  • Ability to collaborate effectively with stake-holders

罗氏是一家提供均等机会的雇主。

Research & Development、 Research & Development > Modelling & Simulation

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