JVT Advisors

IT Project Manager Lab Systems

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Location: Waltham, Massachusetts 02451
Employment Type: Contract

Job Description

IT Project Manager (Clinical/Regulatory), Onsite in Waltham

JOB SUMMARY

  • Seeking a seasoned IT Project Manager with a strong background in the Clinical and/or Regulatory area. 
  • You will lead and manage software implementation projects related to business and systems initiatives within the clinical space.
  • Data Lake or cloud-based project experience preferred
  • You will work closely with all internal groups and external third-party service providers to establish project plans which consider critical tasks, durations and dependencies.
  • You will be expected to be autonomous in management of meetings, solicitation of agendas, distribution of meeting minutes, tracking completion of action items and regular updates on project status. 

Description    

  • Manage projects using project management best practices and following required SDLC policies
  • Elicit requirements using interviews and workshops, document analysis and business process descriptions, use cases, scenarios, business analysis, task and workflow analysis
  • Create and distribute documentation as needed: Functional Requirements, Business Requirements, Use Cases and End-to-End testing documents, Data Flow Diagrams
  • Serve as the conduit between the customer community (internal and external customers) and the software development team (external vendors)
  • Build and foster effective relationships between the business and IT and oversee vendor relationships
  • Introduce best practice and process improvement ideas and ensure adherence to FDA computer systems validation compliance

Experience

  • 5+ years of pharmaceutical/biotech industry experience is MUST
  • Proven track record to lead a small-to-mid-sized team
  • Enterprise information management systems and software vendor selection
  • Demonstrated ability to manage several complex projects at the same time
  • Experience working with third-party implementers
  • PMI or equivalent certification preferred
  • Managing cloud/SaaS based application implementations
  • Domain knowledge of clinical/regulatory requirements/guidance/compliance areas (e.g. eTMF, ICH guidelines, GCP regulations) preferred.

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Zack Lisien

Recruiter

Zack uses traditional and digital resources to keep our talent pool brimming with highly skilled and qualified technology innovators searching for opportunities.

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