Validation Manager Clinical Systems (f/m/d)

Responsibilities

• Support the end-to-end lifecycle of eClinical Systems
• Manage access to the eClinical Systems for internal and external users
• Understand business goals to effectively translate business needs into system and process improvements
• Ensure that eClinical Systems are in compliance and fit for intended use in accordance with applicable Standard Operating Procedures (SOPs)
• Identify process inefficiencies and compliance gaps, participate in process improvement initiatives and drive process implementation
• Create eClinical Systems generated reports as requested by stakeholders with a goal to improve eTMF compliance and quality
• Manage eTMF dictionaries and keep it up-to-date adding new terms as needed
• Ensure eClinical Systems (eTMF, eDMS and CTMs) meet internal and external quality standards and best practices
• Key participant in inspection readiness activities
• Collaborate with clinical study teams in the preparation and follow-up for internal and/or external audits/inspections
• Develop and deliver training to end users to ensure optimal use of processes, eClinical Systems, and tools
• Provide support in eTMF system validation/migration/updates, improve eTMF functionality as needed, create and maintain robust eTMF processes and associated documents (SOP/Working Instructions etc.)
• May assist in the management of eClinical Systems vendor´s oversight
• Lead or assist other document management projects and activities as assigned by management, in support of the eClinical Systems function

Requirements

• BA/BS in life sciences or a healthcare related field
• 4+ years of experience in the Clinical Operations incl. at least 2 years’ experience with electronic Clinical systems (Validation experience is preferred).
• At least one year experience in supporting a eTMF system (like Veeva) is required, experience in supporting Generis eTMF system is preferred.
• Broad knowledge of document management processes and procedures, electronic document management systems, data retrieval, and electronic file formats
• Understanding of clinical trial processes
• Knowledgeable in (pharma) industry document management requirements (GxP)
• Experience with electronic document management software (eTMF, CTMS and eDMS), principles of information systems, and related technology
• Experience with records and/or document management standards
• Excellent written, oral, and interpersonal communication skills; fluent in English
• Ability and willingness to work in a high-visibility, fast-paced environment while handling multiple priorities
• Ability to work successfully within a cross-functional team
• Must be able to interact, communicate and present technical information to individuals at all levels of the organization

Opportunity

• Multifaceted and responsible position, working on innovative projects in an international environment with strong team spirit
• Space for commitment and personal initiative with the possibility for personal and professional growth
• Attractive, performance-related compensation package and further benefits:
  • Employee financial participation in form of stock options
  • Attractive pension allowance from employer
  • Low-cost use of public transportation Job-/Deutschlandticket
  • Free parking spaces
  • Bike Leasing
• Flexible working time, possibility to partially work remotely (depending on function)
• Regular company events such as Culture Day, Summer Get-Together, participation in charity events

We are looking forward to receiving your application incl. motivation letter and salary expectations.

For any queries, please contact Susanne Hering (Tel: 06221 6743 675, e-mail: s.hering@affimed.com).

August 2023