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Home-Based Senior Clinical Data Manager

New Jersey All, NJ

Posted: 06/04/2019 Job Type: Clinical Job Number: JN -062019-25018
  • Performs and oversees data management activities in order to provide high quality data that meets client/project needs
  • Ensures that data is processed and tracked in alignment with regulatory and quality standards
  • Acts as the client's primary point of contact for data-related activities and processing, tracking, and managing clinical data and documentation
  • Ensure that data is processed and tracked in alignment with regulatory and quality standards
  • Project manages all data deliverables; liaising with project stakeholders such as project and data operations teams; and administering clinical documentation
  • Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction
  • Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs
  • Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables

Client Management:

  • Serve as primary point of contact for customer on data management deliverables
  • Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
  • With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources
  • Maintain strong customer relationships
  • Ensure open communications with customer and internal management to manage and meet contractual obligations

Service Management:

  • Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
  • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
  • Support DM service delivery with comprehensive DM process and technical expertise in executing projects
  • Serve as the escalation point for unresolved data issues; with guidance, work with client data managers, vendors, internal team members for resolution
  • Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
  • Create and/or review and sign-off on all data management plan (DMP) documents
  • Implement proactive quality management plan
  • Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve
  • With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
  • Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
  • Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution
  • Maintain internal tracking databases and systems

Financial Management/Business Development Support:

  • With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
  • Manage SOW/budget
  • Review financial reports on a monthly basis and participate in project reviews as requested
  • Identify out of scope tasks and track change orders to completion
  • May serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
  • With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense)

Other:

  • Provide input on DM process improvements or project solutions to CDM team/CDM department
  • Provide input on the development and implementation of a new technology or tool
  • Participate in a focus team or global or local best practice team

Requirements:


BA/BS Degree

6-10+ years of Clinical Data Management experience

2+ years of Lead experience

Client facing experience

Excellent interpersonal skills

CRO experience is a plus

Ability to manage multiple trials simultaneously

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