eClinical Manager - eTMF and Collaboration;eClinical Manage
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
- 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