Klinische Studien, Outsourcing und Contract Management
Aktualisiert am 16.07.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.08.2024
Verfügbar zu: 100%
davon vor Ort: 20%
Clinical Outsourcing
Clinical Operation
klinische Studien
Englisch
Verhandlungssicher
Deutsch
Muttersprache

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2 Jahre 8 Monate
2022-02 - heute

construction, negotiation and ongoing management

Clinical Outsourcing Specialist
Clinical Outsourcing Specialist
  • 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.

Helsinn Healthcare SA CH
12 Jahre 5 Monate
2012-05 - heute

Support of Medical Device companies complying

Founder & Owner
Founder & Owner
  • 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

gladly on request
14 Jahre 3 Monate
2010-07 - heute

Affiliates and Administration

Executive Vice President
Executive Vice President
  • Full responsibility for the integration of Progenitor International Research and Encorium Inc.

Encorium Inc. Helsinki FIN
2 Jahre 6 Monate
2015-01 - 2017-06

construction, negotiation and ongoing management

Clinical Procurement Consultant
Clinical Procurement Consultant
  • 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.

Novartis AG, Basel CH
4 Jahre 11 Monate
2005-08 - 2010-06

Provided executive level oversight

Founder and CEO
Founder and CEO

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

gladly on request
3 Jahre 1 Monat
2001-04 - 2004-04

Contract Management

Head
Head
  • 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.

Schwarz Pharma AG, Monheim, Germany ? Raleigh, NC, USA
2 Jahre 6 Monate
1997-07 - 1999-12

pharmaceutical development

General Manager & CSO, Founder
General Manager & CSO, Founder
  • Founder, Owner and Managing Director of a pharmaceutical development and marketing company for blood plasma derived pharmaceutical

gladly on request
Münster, Germany
2 Jahre 3 Monate
1995-04 - 1997-06

operational activities, Developing and implementing a strategic business plan

Director of Clinical Operations (Full power of attorney)
Director of Clinical Operations (Full power of attorney)
  • 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.

Monitoring Force GmbH, Münster, Germany
4 Jahre 11 Monate
1990-05 - 1995-03

Monitored international clinical trials

Clinical Research Associate
Clinical Research Associate
  • Monitored international clinical trials in accordance with GCP, guidelines and company?s SOPs.

Wyeth Pharma GmbH (American Home Products)
Münster, Germany and Basel, Switzerland

Aus- und Weiterbildung

Aus- und Weiterbildung

1985 -1990

Westfaelische-WIlhelms-Universität, Münster, Germany

Registerd Pharmacist (Apotheker)

1977 -1979

Siegerlandkolleg, Siegen, Germany

General qualification for university entrance (Abitur)

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2 Jahre 8 Monate
2022-02 - heute

construction, negotiation and ongoing management

Clinical Outsourcing Specialist
Clinical Outsourcing Specialist
  • 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.

Helsinn Healthcare SA CH
12 Jahre 5 Monate
2012-05 - heute

Support of Medical Device companies complying

Founder & Owner
Founder & Owner
  • 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

gladly on request
14 Jahre 3 Monate
2010-07 - heute

Affiliates and Administration

Executive Vice President
Executive Vice President
  • Full responsibility for the integration of Progenitor International Research and Encorium Inc.

Encorium Inc. Helsinki FIN
2 Jahre 6 Monate
2015-01 - 2017-06

construction, negotiation and ongoing management

Clinical Procurement Consultant
Clinical Procurement Consultant
  • 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.

Novartis AG, Basel CH
4 Jahre 11 Monate
2005-08 - 2010-06

Provided executive level oversight

Founder and CEO
Founder and CEO

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

gladly on request
3 Jahre 1 Monat
2001-04 - 2004-04

Contract Management

Head
Head
  • 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.

Schwarz Pharma AG, Monheim, Germany ? Raleigh, NC, USA
2 Jahre 6 Monate
1997-07 - 1999-12

pharmaceutical development

General Manager & CSO, Founder
General Manager & CSO, Founder
  • Founder, Owner and Managing Director of a pharmaceutical development and marketing company for blood plasma derived pharmaceutical

gladly on request
Münster, Germany
2 Jahre 3 Monate
1995-04 - 1997-06

operational activities, Developing and implementing a strategic business plan

Director of Clinical Operations (Full power of attorney)
Director of Clinical Operations (Full power of attorney)
  • 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.

Monitoring Force GmbH, Münster, Germany
4 Jahre 11 Monate
1990-05 - 1995-03

Monitored international clinical trials

Clinical Research Associate
Clinical Research Associate
  • Monitored international clinical trials in accordance with GCP, guidelines and company?s SOPs.

Wyeth Pharma GmbH (American Home Products)
Münster, Germany and Basel, Switzerland

Aus- und Weiterbildung

Aus- und Weiterbildung

1985 -1990

Westfaelische-WIlhelms-Universität, Münster, Germany

Registerd Pharmacist (Apotheker)

1977 -1979

Siegerlandkolleg, Siegen, Germany

General qualification for university entrance (Abitur)

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