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Title:Manager Clinical Data
Salary:Open
Experience:8+
Location:MA - Cambridge

Description:
Manage a team of experienced data management staff (4-5) who support four Lysosomal Storage Disorder Registries.

Responsibilities:
  • Provide functional line management for multiple projects and prioritize with respect to project plans and timelines.
  • Participate in cross-functional project team meetings, as needed, and serve as an escalation point for troubleshooting and resolving issues.
  • Participate in the development and implementation of new technology.
  • Participate in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines for data management activities.
  • Assist with the development of training needs and ensure staff are trained and adhere to project-specific, global, and standardized registry data management guidelines.
  • Provide expert review and help in the development of CRF/eCRF design specifications, database design specifications, validation specifications and report design, etc.
  • Work with Electronic Data Capture (EDC) vendors to help troubleshoot and coordinate problem reporting and resolution.
  • Work with staff to coordinate and develop operational type reports to assist with data review and metrics.
  • Work with staff to facilitate productive monthly data management meetings with EU colleagues.
  • Meet with senior management weekly to communicate project status and resource allocation.
  • Set goals, evaluate, document performance, and prepare and deliver performance reviews based on HR polices and procedures.

Requirements:
  • Bachelor’s degree in related science/technical discipline
  • Minimum of 8 years data management experience in Pharmaceutical/Biotechnology industry.
  • Minimum of 3 years management experience.
  • Knowledge and experience with developing and implementing data management SOPs, Work Instructions, Guidelines and Forms.
  • Knowledge and experience with developing and implementing Electronic Data Capture (EDC) system and other data management systems.
  • Ability to juggle multiple tasks and priorities.
  • Analytical and problem-solving skills, with good attention to detail.
  • Excellent communication skills (oral and written) and interpersonal skills.

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