Detlef Nehrdich
DM Director
Experience
Contract Research Organization (CRO)
- Project: Prove of concept project to replace resource intense repetitive tasks by semi-automated processes powered by generative artificial intelligence (AI)
- Achievements: Existing processes reviewed, new processes and AI tools in implementation phase
Small Contract Research Organization (CRO)
- Specialized on Biostatistics services
- Project: Business Consulting to CEO
- Achievements: Business opportunities identified, processes reviewed
Biotech Company
Project: Process Consulting to CEO, review and development of major clinical development processes
Achievements: Existing processes reviewed, new processes and tools in set-up phase
Project: Process Consulting to VP of Data Science & Biomarker Analysis
Achievements: Processes defined to manage internal tasks, re-design of task management tool. Optimization of workload processing and prioritization
Top 10 Pharma Company
- Project: Gap analysis of external clinical data oversight within R&D organization
- Achievements: Analysis completed and multiple ideas for optimization and improvement measures shared.
Medical Device Company
- Project: Develop and implement a risk based monitoring (RBM) process including the development of KPIs
- Achievements: RBM process defined, tested and implemented including visualization and documentation tools
DM Director
Contract Research Organization (CRO)
- Specialized on Data Sciences, Data Management, and Biostatistics services
- Project: Business Process Consulting to General Managers, process and technology evaluation for Data Management organisation, coaching of several contributors, day-to-day support of Data Management activities, interim management as DM Director
- Achievements: Multiple process re-designs implemented, internal technology set-up re-designed
Medical Device Company
- Project: Process and technology evaluation of clinical research organization
- Achievements: Workflow and technology analysis completed, recommendations presented and discussed with R&D management
Academic Clinical Research Institute
- Focussed on breast cancer research
- Project: Business Consulting to General Manager, process development for Data Management organisation, coaching of Head of Data Management, day-to-day support of Data Management activities, selection of new IT service provider and implementation of new data storage area including development of IT SOPs
- Achievements: Process development completed, coaching completed, leadership development progressed, IT service provider and SOPs in operation
Mid-sized Biopharmaceutical Company
- Project: Collection, mediation and reporting of investigator assessments of study results in light of data issues via eCOA tool
- Achievements: Face-to-face interviews with study investigators, preparation of a report and recommendations for client on usage and interpretation of investigator feedback
Mid-sized Biopharmaceutical Company
- Project: Assessment of issues in data collected via eCOA tool
- Achievements: Process and document review, preparation of for-cause-audit, providing of recommendations on eCOA data usage and future preventive actions
Interim Manager
Software Company
- Provider of Quality Management solutions for hospitals
- Project: Business Consulting to General Managers, Interim Management Customer Support, Interim Management HR
- Achievements: Process and document review, coaching, leadership and strategy workshops, initiation of company restructuring, cross-functional project initiation, recruitment of leadership personnel
Top 30 Pharma Company
- Project: Design, development and process definition for resource and metrics database for global R&D Informatics Department
- Achievements: Assisted client to design and develop a global resource and metrics database including development of business requirements, interactions with technology service provider to allow for best results for client
IT Project Manager
Top 10 Pharma Company
Project: Project Management of a major update of the global Clinical Data Repository system
Achievements: IT project management, stakeholder management, vendor management, facilitation, encouragement and support of process re-design
Project: Design of processes, tools and background databases for a Risked Based Monitoring concept
Achievements: Defined robust Risked Based Monitoring processes, including tools and background databases. Conceptualized KRIs, good documentation practices and stress tested system to prepare implementation. Coaching of personnel involved
Project: Workflow optimization of global pharmacovigilance operations
Achievements: Workflow and technology evaluation, identification of process gaps, system flaws and interdependencies of issues, development of a set of recommendations for process improvements and technology adjustments
Top 10 Pharma Company
Project: Review of current practice in the global Data Management department
Achievements: Review of current Data Management processes, CRO interactions and development of a set of recommendations. Development of process maps for new, state-of-the art processes, creation of a new Data Management SOP and a set of corresponding Guidelines
Project: Assessment of global Data Management Department (360+ people, 3 major sites) and preparation for future challenges
Achievements: Review of processes, roles, tools, the organization of work and vendor management. Face-to-face interviews in USA, Europe and India on executive and working level within and outside of Data Management. Provisioning of a set of recommendations
Mid-sized Pharma Company
- Project: Revision of Study Start-up processes. Development of and implementation support for a new Vendor Oversight Management strategy for Statistics, Medical Writing and Data Management
- Achievements: Interviews with cross-functional stakeholders in US and Europe. Development of new cross-functional Study Start-up processes. Multiple workshops to define business needs and actual new strategy for Vendor Oversight Management. Preparation and conduct of two role-playing workshops on Vendor Oversight Management for all department members. Individual coaching of selected department members to ensure proper implementation
Top 10 Pharma Company
Project: Assessment and re-design of the Global Clinical Development organization including Clinical Operations, Pharmacovigilance, Epidemiology, Statistics, Medical Writing, Data Management, Database Programming
Achievements: Review of eClinical strategy including EDC system versioning and electronic patient diaries. Interviews and multiple workshops on the revision of the cross-functional Data Cleaning processes. Preparation and facilitation of a SWOT workshop for the Epidemiology department. Development of alternative operating models for Statistical Programming. Review of Statistical Programming and DB Programming processes (mock data handling, additional analysis, programming concept, lab data handling) and recommendations for changes. Individual coaching of selected team members on revised processes and change management
Project: Assessment of the Global Data Management organization (300 people, 5 locations, 3 continents) and development of a future concept for Data Management
Achievements: Interviews with globally distributed department members at all levels and with Data Management customers. Detailed review of processes, metrics and tools. Workshop with internal "high potentials" on their perspective of desired future state. Provisioning of a detailed report with description of strengths, areas for improvement and potential development needs
Top 30 Pharma Company
Project: Development of a process overview for global R&D Informatics Department
Achievements: Review of all major clinical R&D processes and creation of corresponding process maps. Face-to-face interviews with process owners and stakeholders. Provisioning of a set of recommendations
Project: Evaluation and selection a global Regulatory Affairs system
Achievements: Process and document review, interviews with globally distributed and cross-functional project stakeholders. Preparation, facilitation and documentation of vendor evaluation and vendor selection workshops
Project: Evaluation, selection and implementation of a new global EDC system
Achievements: Interviews with globally distributed and cross-functional project stakeholders. Preparation and facilitation of workshops to define company's EDC business requirements, live system review and reference visits to other vendor clients. Facilitation of Vendor Selection meeting. Preparation, facilitation and documentation of multiple process review workshops with cross-functional representation to define revised processes. Developments of project communication plan, training material and SOPs. Preparation and conduct of a "Mock Trial" as preparation for system implementation
Project: Evaluation of the need and potential selection of a Clinical Trial Management System
Achievements: Process and document review and interviews with globally distributed and cross-functional project stakeholders. Recommendation to develop a sponsor specific application
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