eClinical Manager - eTMF and Collaboration;eClinical Manage

CSL   •  

King Of Prussia, PA

Industry: Medical Devices & Diagnostics


5 - 7 years

Posted 394 days ago

This role will take leadership in identifying, implementing and provisioning state of the art collaboration and document managementtools to clinical study teams.

eClinical Manager – eTMF & Collaboration (m/f)

(fulltime / permanent)

Main Responsibilities and Accountabilities

  • Lead design, implementation, validation, and maintenance of global R&D systems and related infrastructure. This includes but is not limited to Document Management and Collaboration
  • Contribute to all aspects of system life cycle, representing the business to ensure that user requirements are translated to sound implementation and configuration that will meet the long-term needs
  • Partner with IT and external vendors to establish development infrastructure and process to provide global and study specific solutions.
  • Establish and maintain partnerships with R&D business functions, partner business functions like Commercial or IT and external vendors 
  • Lead cross functional teams supporting development of global systems and processes and maintaining a streamlined interface between product development and system interface/usage
  • Liaises with key stakeholders to ensure understanding of the nature of R&D System services required to deliver on program requirements.
  • Collaborates with global R&D, IT, Procurement and Contracts staff in the selection of relevant Vendors.

Qualifications / experience

  • University/College degree (BSc, MSc, Diploma) in an IT, technical or life science discipline or similar education
  • At least 5 years of experience in Clinical Research/Regulatory Affairs or IT with profound knowledge of pharmaceutical specifically in the area of Document Management and submission management
  • Strategic development and business analyst skills
  • Strong analytical skills with a focus on process mapping and Business URS development
  • Comprehensive understanding of R&D processes, including knowledge of ICH-GxP regulations andR&D

    process know-how

  • Experienced in Computer System Validation
  • Experienced with DIA TMF Reference Model and eCTD
  • Excellent communication and training skills, including English language skills
  • Excellent organizational and time management skills
  • Attention to detail