Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers.

To strengthen our highly motivated Clinical Operations Team in Mannheim, Germany, we are looking for a full-time

Validation Manager Clinical Systems (f/m/d)

(Reference No. C2302)

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  • 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


  • 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


  • 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:

August 2023

Your application