Detlef Nehrdich teilweise verfügbar

Detlef Nehrdich

Freiberuflicher Berater und Interims Manager

teilweise verfügbar
Profilbild von Detlef Nehrdich Freiberuflicher Berater und Interims Manager aus Freinsheim
  • 67251 Freinsheim Freelancer in
  • Abschluss: Diplom- Statistiker
  • Stunden-/Tagessatz: 1250 €/Tag
    je nach Aufgabe ggf verhandelbar
  • Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (Grundkenntnisse)
  • Letztes Update: 10.09.2019
SCHLAGWORTE
PROFILBILD
Profilbild von Detlef Nehrdich Freiberuflicher Berater und Interims Manager aus Freinsheim
DATEIANLAGEN
Lebenslauf
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Projekterfahrungen
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SKILLS
Ich bin seit über 25 Jahren überwiegend in der pharmazeutischen Industrie tätig. Meine Laufbahn habe ich als Biostatistiker in der pharmazeutischen Industrie begonnen und schon früh habe ich Führungsverantwortung übernommen. 2002 erfolgte der Sprung zum Einheitsleiter in einem amerikanischen Großunternehmen in Ludwigshafen. Neben der gewachsenen Führungsverantwortung habe ich dort einige globale Projekte zur Prozessoptimierung und Digitalisierung geleitet. Seit 2012 bin nun beratend tätig im internationalen, pharmazeutischen Sektor genauso wie auf lokaler Ebene als Interimsmanager, HR Berater, Coach, Projektleiter und als Gestalter, Begleiter und Unterstützer in Veränderungsprozessen.
REFERENZEN
Detlef Nehrdich: Project Experience (Apr 2012 - Feb 2019)

May 2016 to Dec 2019:
Client:                                            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, inititation of company restructuring, cross
functional project initiation, recruitment of leadership personnel

Dec 2018:
Client:                                            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

Jun 2016 to Dec 2017:
Client:                                            Top 10 Pharma company 
Project:                                          Project Management of an major update of the global ClinicalData Repository system
Achievements:                               IT project management, stakeholder management, vendor management, facilitation, encouragement and support of process re-
design

Nov 2015 to Feb 2016:
Client:                                            Top 10 Pharma company 
Project:                                          Workflow optimization of global pharmacovigilance operations
Achievements:                               Workflow and technology evaluation, identification of process gaps, system flaws and interdependcies of issues, development
of a set of recommendations for process improvments and technology adjustments

Jun 2015 to Jun 2016:
Client:                                            Top 10 Pharma company 
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 personel involved.

Jun 2015 to Oct 2018:
Client:                                            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

Jan 2015 to Apr 2015:
Client:                                            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

Nov 2014 to Jan 2015:
Client:                                            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, 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.

Aug 2014 to Nov 2014:
Client:                                            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.

Oct 2012 to Jun 2014:
Client:                                            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.

Jun 2012 to Mar 2014:
Client:                                            Top 30 Pharma company
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.

Apr 2014 to Jul 2014:
Client:                                            Top 30 Pharma company
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.

Feb 2013 to Apr 2013:
Client:                                            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 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.

Aug 2012 to Jun 2013:
Client:                                            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.

Apr 2012 to Aug 2012:
Client:                                            Top 30 Pharma company 
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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