Detlef Nehrdich
Principal Management Consultant
Experience
Nov 2024 - Present
8 months Lorem ipsum dolor sit amet
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
Jul 2024 - Nov 2024
5 months Lorem ipsum dolor sit amet
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
May 2024 - Present
1 year 2 months Lorem ipsum dolor sit amet
Small Contract Research Organization (CRO), specialized on Biostatistics services
- Project: Business consulting to CEO
- Achievements: Business opportunities identified, processes reviewed
May 2024 - Sep 2024
5 months Lorem ipsum dolor sit amet
Biotech Company
- Project: Process consulting to VP of Data Science & Biomarker Analysis
- Achievements: Processes defined to manage internal tasks, redesign of task management tool, optimization of workload processing and prioritization
Nov 2021 - Dec 2021
2 months Lorem ipsum dolor sit amet
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
Sep 2021 - Dec 2022
1 year 4 months Lorem ipsum dolor sit amet
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
Jul 2021 - Jul 2023
2 years 1 month Lorem ipsum dolor sit amet
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 redesigns implemented, internal technology set-up redesigned
Apr 2021 - Jun 2021
3 months Lorem ipsum dolor sit amet
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
Jul 2020 - Mar 2024
3 years 9 months Lorem ipsum dolor sit amet
Academic Clinical Research Institute, focused 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
Oct 2019 - Dec 2020
3 months Lorem ipsum dolor sit amet
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
Dec 2018 - Present
6 years 7 months Lorem ipsum dolor sit amet
Mid-sized Biopharmaceutical Company
- Project: Assessment of issues in data collected via eCOA tool
- Achievements: Process and document review, preparation of for-cause-audit, recommendations on eCOA data usage and future preventive actions
Jun 2016 - Dec 2017
1 year 7 months Lorem ipsum dolor sit amet
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 redesign
May 2016 - Dec 2019
2 years 8 months Lorem ipsum dolor sit amet
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
Nov 2015 - Feb 2016
4 months Lorem ipsum dolor sit amet
Top 10 Pharma company
- Project: Workflow optimization of global pharmacovigilance operations
- Achievements: Workflow and technology evaluation, identification of process gaps, system flaws and interdependencies of issues, development of recommendations for process improvements and technology adjustments
Jun 2015 - Oct 2018
3 years 5 months Lorem ipsum dolor sit amet
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
Jun 2015 - Jun 2016
1 year 1 month Lorem ipsum dolor sit amet
Top 10 Pharma company
- Project: Design of processes, tools and background databases for a risk based monitoring concept
- Achievements: Defined robust risk based monitoring processes, including tools and background databases; conceptualized KRIs; good documentation practices; stress tested system; coaching of personnel
Jan 2015 - Apr 2015
4 months Lorem ipsum dolor sit amet
Top 10 Pharma company
- Project: Review of current practice in the global Data Management department
- Achievements: Review of current Data Management processes, CRO interactions; development of recommendations; process maps for new processes; creation of a new Data Management SOP and guidelines
Nov 2014 - Jan 2015
3 months Lorem ipsum dolor sit amet
Top 10 Pharma company
- Project: Assessment of global Data Management department (360+ people, 3 major sites) and preparation for future challenges
- Achievements: Review of processes, roles, tools, organization of work and vendor management; face-to-face interviews in USA, Europe and India; recommendations
Aug 2014 - Nov 2014
4 months Lorem ipsum dolor sit amet
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; creation of process maps; face-to-face interviews with process owners and stakeholders; recommendations
Apr 2014 - Jul 2014
4 months Lorem ipsum dolor sit amet
Top 30 Pharma company
- Project: Evaluation and selection of a global Regulatory Affairs system
- Achievements: Process and document review; interviews with globally distributed stakeholders; vendor evaluation and selection workshops
Feb 2013 - Apr 2013
3 months Lorem ipsum dolor sit amet
Top 10 Pharma company
- 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 department members and customers; detailed review of processes, metrics and tools; workshop with internal high potentials; detailed report with strengths, improvement areas and development needs
Oct 2012 - Jun 2014
1 year 9 months Lorem ipsum dolor sit amet
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; role-playing workshops on Vendor Oversight Management; individual coaching
Aug 2012 - Jun 2013
11 months Lorem ipsum dolor sit amet
Top 10 Pharma company
- Project: Assessment and redesign of the global Clinical Development organization including Clinical Operations, Pharmacovigilance, Epidemiology, Statistics, Medical Writing, Data Management, Database Programming
- Achievements: Review of eClinical strategy; interviews and workshops on data cleaning; SWOT workshop for Epidemiology; alternative operating models for Statistical Programming; review of programming processes; individual coaching
Jun 2012 - Mar 2014
1 year 10 months Lorem ipsum dolor sit amet
Top 30 Pharma company
Project: Evaluation, selection and implementation of a new global EDC system
Achievements: Interviews with globally distributed stakeholders; workshops to define EDC business requirements; live system review and reference visits; vendor selection facilitation; process review workshops; communication plan, training material and SOPs; mock trial preparation
Apr 2012 - Aug 2012
5 months Lorem ipsum dolor sit amet
Top 30 Pharma company
- Project: Evaluation of the need and potential selection of a Clinical Trial Management System
- Achievements: Process and document review; interviews with globally distributed stakeholders; recommendation to develop a sponsor specific application
Summary
As a roadblock remover, I guide people through change. I help them to understand the opportunities and the limitations of technology. I have a deep understanding of clinical development processes. I learn quickly, I am an experienced leader and an effective project manager. My current focus is the use of AI for the automation of routine processes in clinical development.
Languages
German
Native
English
Advanced
French
Elementary
Education
University Dortmund
Diploma, subsidiary subject: Sociology · Statistics · Dortmund, Germany
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