Document Control Experts in Germany

Study Contract Manager (SCM) for the global CRO Thermo Fisher GmbH in cooperation with the global pharmaceutical company Astra Zeneca in the department of Cell Therapy Clinical Operations

Following activities are included:

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
• Develop and negotiate clinical site budgets based on Fair Market Value.
• Negotiate agreement language and budget with clinical study sites.
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
• Support internal and external audit activities.
• Ensure compliance with AstraZeneca's Code of Conduct and company policies and procedures relating to people, finance, technology and security.
• Ensure that all contracts are included in the TMF
• Support preparation and negotiation of a Local Master Service Agreement
• Contribute to process improvements, knowledge transfer and best practice sharing.

• Requirements management, process planning, interface role, ISMS implementation and documentation
• Implementation and establishment of an ISMS according to ISO 27001 as well as setup of emergency management / ITSCM
• Coordination of conditions with the authority-affiliated IT service provider
• Consideration of KRITIS relevance in the scope and implementation of a B3S
• Development of guidelines for document control and the continuous improvement process (KVP)
• Creation of relevant project documents
• Analysis of existing processes and development of guidelines
• Collection of requirements for ISMS and ITSCM and coordination with the IT service provider including definition of interfaces
• Analysis of communication processes and escalation paths
• Review of documents for risk management, ISMS, emergency preparedness and emergency response
• Development of a complete rebuild of all documentation and creation of new relevant documents
• Development of necessary rules, policies and concepts
• Interface function between customer and service provider to ensure document quality
• Coordination of protection needs with departments, especially regarding KRITIS relevance, and planning resulting measures
• Development of preventive measures to minimize data center outages for various scenarios such as pandemics or ransomware attacks
• Defining the test strategy for IT emergency exercises
• Initiation of necessary training measures for raising awareness in departments
• External Information Security Officer (ISB)
• Introduction of document control

• Projects for federal networks (NdB).
• CR management, EoL change requests, design and documentation according to ITSCM.
• Data center planning.
• Project management and engineering subproject management.
• Software development for virtual server environments according to BSI.

• Creating, maintaining, and managing a detailed customer database
• Identifying and generating leads for business development
• Initiating first contact with potential clients to foster new business relationships
• Creating compelling presentations to support lead generation and business development activities
• Assisting with various business development tasks
• Helping various executives with translations and bilingual communication tasks
• Supporting management with social media communication by preparing and posting relevant content
• Coordinating with internal teams for the seamless implementation of marketing and business development strategies
• Performing additional tasks as required by business needs

• Analyzed multi-source datasets using information-theory metrics such as permutation entropy, informational complexity, and decision-support models.
• Developed algorithms and data visualizations in MATLAB and Python.
• Conducted research and co-authored multiple peer-reviewed scientific publications based on the findings.
• Electrical project design and execution
• Digitalization and smart systems integration
• Supplier and contractor coordination
• Risk and quality management
• Strategic decision making
• Financial and ROI perspective
• Analytical and systemic thinking
• Data-driven decision support
• Problem solving and critical thinking
• Cross-functional team leadership
• Influential leadership

• Maintain internal GDPR documentation and manage data access controls within digital systems.
• Train users on privacy protocols, recordkeeping, and document management standards.

• Perform validation or qualification tests on new or existing processes, IT modules, equipment, Clinical trial software in compliance with internal norms or external standards.
• Resourceful in reviewing various documents, including VMP, URS, System Requirement Specification (SRS) and/or Functional/Technical Specification, Design Qualification (DQ), Risk Assessment (RA) with ALCOA CCEA, IQ, OQ, PQ, Traceability Matrix (TM), Compliance Report (CR), and Validation Summary Report (VSR), in accordance with regulatory requirements and quality management systems.
• Perform testing activities with Microfocus ALM and handle faults and deviations.
• Familiar with regulatory standards (such as FDA/GxP, records management, and disaster recovery).
• Proven expertise in risk management, FMEA, audit management, and periodic compliance reviews.
• Proficiency in change management and control procedures, deviation management, incident management, and CAPA escalation.
• Implementing a Quality System to meet GxP standards and ensure regulatory compliance through inspections, data review, and training.
• Conduct internal audits on processes and systems, prepare for external audits, and verify compliance with internal standards and SOPs.
• Develop and review SOPs and papers in accordance with regulatory norms.
• Organized and reviewed cGMP training records.

• Consulting on quality management and operational quality assurance (software testing)
• Creating binding templates for quality-related documents based on DIN EN ISO 9000 ff. and NATO AQAP standards
• Advising on document control and approval processes
• Reviewing and approving project-related documents
• Proofreading English-language white papers in basic research
• Implementing corporate design/identity guidelines
• Supporting audits

• Auditing CIS evidence of the SOC providers T-Systems Austria and Cancom GmbH
• Mapping of VAIT, ISO:IEC 27002 and CIS 7.0 requirements for the IT realignment strategy of the German subsidiaries in threat intelligence and zero trust
• Reviewing SIEM evidence, reporting, incident management and security breaches
• Reviewing IT asset management regarding ITSCM and BCM processes
• Employee awareness and compliance training focused on CEO fraud
• Advising the chief information security officer

• Embedded EWM – FIT migration, UAT migration, and cutover
• Download and cleanup of all material master data and stock levels from the R/3 system
• Preparation of material master data, EWM product master data, packaging specifications (2-level), storage bins, storage locations, IM stocks, EWM stock, batches and serial numbers
• Testing and documentation in SAP Solution Manager (SolMan)
• Upload to S/4HANA using LTMC, Fiori App Migration Cockpit, and Migrate Your Data
• Creation of migration objects and mapping in the Migration Cockpit
• Creation of SAP queries for data download
• Data cleansing involving business departments, preparation of data in Excel, and upload including handling of mapping and simulation errors

• Focus: Developing a central platform to manage user flows and data between survey tools and marketing systems.
• Technology: Laravel middleware with Keycloak integration.