Responsibilities for the construction, negotiation and ongoing management of global contracts with Clinical Research Organizations (CROs), third-party vendors (Data Management, IVRS, Central ECG, Central Labs, Health Care Professionals, etc.).
Consulting in integration of strategic outsourcing projects by creating tool to measure and evaluate the performance of vendors by KPIs, development of strategies to streamline the clinical outsourcing process by implementing proposal evaluation instruments (bid grid), preferred provider identification by RFIs, etc.
Support of Medical Device companies complying with EU MDR 2017/745
Provides international business development support, contract negotiation, standardized bidding processes, consultation and product development support to pharmaceutical, biotechnology, and CRO companies
CRO selection services, vendor selection services, quality assurance oversight; SOP development
Full responsibility for the integration of Progenitor International Research and Encorium Inc.
Responsibilities for the construction, negotiation and ongoing management of global contracts with Clinical Research Organizations (CROs), third-party vendors (Data Management, IVRS, Central ECG/Spirometry, Central Labs, Consultants, Health Care Professionals, etc.) and other providers as necessary for the successful execution of global clinical trials and pharmaceutical research endeavors.
Provided executive level oversight and management of all activities of Progenitor International
Research in Latin America, India and Far East. Vaccine focussed CRO:
Global project responsibility for a 23.000 Patients vaccine study in LATAM for global big Pharma
Project Responsibility for eight vaccine studies in PR China
Consulting Crucell/Berna Biotech in four vaccine projects
Responsibilities included the construction, negotiation and ongoing management of global contracts with Clinical Research Organizations (CROs), third-party vendors (data management service providers, central ECG-reading providers, laboratory service providers, and consultants) and other providers as necessary for the successful execution of global clinical trials and pharmaceutical research endeavors.
Founder, Owner and Managing Director of a pharmaceutical development and marketing company for blood plasma derived pharmaceutical
Responsible for operational activities, Developing and implementing a strategic business plan to build up a Clinical Research Organization in accordance with all legal and regulatory requirements.
Monitored international clinical trials in accordance with GCP, guidelines and company?s SOPs.
various projects
Role: Contract/Outsourcing Manager (OM)
Tasks:
Support the selection of the optimum External Service Provider (ESP): CRO, Central/Reference Lab, Biostatistics, Data Management, IVRS, e-PRO, Translation and Specialty provider, at both the tactical and strategic level based on fit for purpose, or value-added services, cost avoidance and savings.
Contribute to the development pipeline by providing quality, timely, cost effective and where appropriate value-added external resources, while minimizing regulatory, legal, financial risks to Sponsor Company?s opportunities.
Train clinical teams in outsourcing procedures, assist Clinical Teams in defining the scope of work, and in some cases defined the scope of work for both original contract and contract amendments.
Negotiate contract terms, scope of work, pricing and payment schedules, in order to assure that the agreements with the ESPs are commercially advantageous to the Company, while minimizing regulatory, legal, and financial risks through close collaboration with functional partner such as Legal, Finance, QA, and functional lines.
Produce final contracts and amendments in order to secure all necessary company approvals including SOP and internal processes compliance to facilitate execution of said agreements.
Manage ongoing ESP collaborations (business conflicts, issue resolution, project status, adherence to budget).
Manage the interface between clinical sourcing, internal key stakeholders and where appropriate External Service Providers to enhance the success of outsourced trials.
Contribute to Protocol Design Meetings and Clinical Development Plans, when and where applicable.
Support the MSA(s) language and rates negotiations for Strategic and non-Preferred External Service Providers.
Contribute to vendor audit requests and facilitate corrective action plans following a QA audit of non-preferred External Service Provider.
Ensure ESPs are delivering in line with expectations by contribute to implementation of Key Performance Indicators (KPI).
Participate in initiatives related to departmental objectives. Participate in initiatives related to Global Development objectives.
1985 -1990
Westfaelische-WIlhelms-Universität, Münster, Germany
Registerd Pharmacist (Apotheker)
1977 -1979
Siegerlandkolleg, Siegen, Germany
General qualification for university entrance (Abitur)
Responsibilities for the construction, negotiation and ongoing management of global contracts with Clinical Research Organizations (CROs), third-party vendors (Data Management, IVRS, Central ECG, Central Labs, Health Care Professionals, etc.).
Consulting in integration of strategic outsourcing projects by creating tool to measure and evaluate the performance of vendors by KPIs, development of strategies to streamline the clinical outsourcing process by implementing proposal evaluation instruments (bid grid), preferred provider identification by RFIs, etc.
Support of Medical Device companies complying with EU MDR 2017/745
Provides international business development support, contract negotiation, standardized bidding processes, consultation and product development support to pharmaceutical, biotechnology, and CRO companies
CRO selection services, vendor selection services, quality assurance oversight; SOP development
Full responsibility for the integration of Progenitor International Research and Encorium Inc.
Responsibilities for the construction, negotiation and ongoing management of global contracts with Clinical Research Organizations (CROs), third-party vendors (Data Management, IVRS, Central ECG/Spirometry, Central Labs, Consultants, Health Care Professionals, etc.) and other providers as necessary for the successful execution of global clinical trials and pharmaceutical research endeavors.
Provided executive level oversight and management of all activities of Progenitor International
Research in Latin America, India and Far East. Vaccine focussed CRO:
Global project responsibility for a 23.000 Patients vaccine study in LATAM for global big Pharma
Project Responsibility for eight vaccine studies in PR China
Consulting Crucell/Berna Biotech in four vaccine projects
Responsibilities included the construction, negotiation and ongoing management of global contracts with Clinical Research Organizations (CROs), third-party vendors (data management service providers, central ECG-reading providers, laboratory service providers, and consultants) and other providers as necessary for the successful execution of global clinical trials and pharmaceutical research endeavors.
Founder, Owner and Managing Director of a pharmaceutical development and marketing company for blood plasma derived pharmaceutical
Responsible for operational activities, Developing and implementing a strategic business plan to build up a Clinical Research Organization in accordance with all legal and regulatory requirements.
Monitored international clinical trials in accordance with GCP, guidelines and company?s SOPs.
various projects
Role: Contract/Outsourcing Manager (OM)
Tasks:
Support the selection of the optimum External Service Provider (ESP): CRO, Central/Reference Lab, Biostatistics, Data Management, IVRS, e-PRO, Translation and Specialty provider, at both the tactical and strategic level based on fit for purpose, or value-added services, cost avoidance and savings.
Contribute to the development pipeline by providing quality, timely, cost effective and where appropriate value-added external resources, while minimizing regulatory, legal, financial risks to Sponsor Company?s opportunities.
Train clinical teams in outsourcing procedures, assist Clinical Teams in defining the scope of work, and in some cases defined the scope of work for both original contract and contract amendments.
Negotiate contract terms, scope of work, pricing and payment schedules, in order to assure that the agreements with the ESPs are commercially advantageous to the Company, while minimizing regulatory, legal, and financial risks through close collaboration with functional partner such as Legal, Finance, QA, and functional lines.
Produce final contracts and amendments in order to secure all necessary company approvals including SOP and internal processes compliance to facilitate execution of said agreements.
Manage ongoing ESP collaborations (business conflicts, issue resolution, project status, adherence to budget).
Manage the interface between clinical sourcing, internal key stakeholders and where appropriate External Service Providers to enhance the success of outsourced trials.
Contribute to Protocol Design Meetings and Clinical Development Plans, when and where applicable.
Support the MSA(s) language and rates negotiations for Strategic and non-Preferred External Service Providers.
Contribute to vendor audit requests and facilitate corrective action plans following a QA audit of non-preferred External Service Provider.
Ensure ESPs are delivering in line with expectations by contribute to implementation of Key Performance Indicators (KPI).
Participate in initiatives related to departmental objectives. Participate in initiatives related to Global Development objectives.
1985 -1990
Westfaelische-WIlhelms-Universität, Münster, Germany
Registerd Pharmacist (Apotheker)
1977 -1979
Siegerlandkolleg, Siegen, Germany
General qualification for university entrance (Abitur)