Freelance Clinical Project Manager @ Freelance | Study Start up /Study Management / Outsourcing Manager / Site Contract Manager
Aktualisiert am 14.08.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 14.08.2024
Verfügbar zu: 100%
davon vor Ort: 20%
Clinical Project Management
Planning / Setup / Surveillance of Clinical Trials phase I -IV
CRO & vendor management outsourcing
Clinical Operations
Planning Budgeting & Forecasting
contract management
Regulatory Compliance
Good Clinical Practice (GCP)
Strategic Sourcing
Risk Assessment
Problem Solving
Easily Adaptable
CAR-T
Gene therapy
Corrective Actions
Oncology
Cell therapy
Study start up
Immunology
Autoimmune
CNS
Gastroenterology and Hepatology
drug development
French
A2 level
Russian
A1 level
Japanese
(very) Basics
Chinese
(very) Basics

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

13 years 8 months
2011-01 - now

diverse

diverse freelance positions
diverse freelance positions
5 months
2023-04 - 2023-08

Management start-up activities phase

Clinical Project Manager
Clinical Project Manager
  • Management start-up activities phase 2/3 oncology global oncology trials (GMO)
  • Review / prepare of study documents (protocol, eCRF, ICF)
  • Oversee submission process
  • Provide support for answering questions from health authorities
  • Vendor selection and define KPIs
  • Management third party vendors
NDA small biotech company/Munich
100% remote
1 year 2 months
2022-02 - 2023-03

Leading and conducting negotiations with sites

Contract Manager (Freelance contract)
Contract Manager (Freelance contract)
  • Leading and conducting negotiations with sites
  • Review, prepare and negotiate site contracts and budgets with sites / PIs
  • Manage budgets
  • Serve as Single Point of Contact (SPOC) in assigned studies for trial sites
  • Supporting start-up activities and submission processes
PPD / Thermo Fisher
100% remote
1 year 10 months
2020-08 - 2022-05

Leading and conducting negotiations with sites

Senior Trial Capabilities Manager (Freelance contract)
Senior Trial Capabilities Manager (Freelance contract)
  • Leading and conducting negotiations with sites
  • Review, prepare and negotiate site contracts and budgets with sites / PIs
  • Manage budgets
  • Serve as Single Point of Contact (SPOC) in assigned studies for trial sites
  • Supporting clinical teams and functions for all their outsourcing needs
  • Management of BfS submissions
  • From 10/21 performing Start up activities DACH region
  • Submit to RAs / ERBs / ECs
  • Serve as Single Point of Contact (SPOC) to RAs / ERBs / Ecs
  • Involved in planning and preparing Initial Trial Application and amendments
  • Responding queries and collaborates with relevant functions
  • Involved in planning, preparing inform consents
GBS Cork, Eli Lilly Ireland
100% remote
2 years 3 months
2019-01 - 2021-03

Responsible for the management of all start-up

Senior Clinical Project Manager (Freelance contract)
Senior Clinical Project Manager (Freelance contract)
  • Responsible for the management of all start-up aspects of 3 multi-centre, Phase III trials conducted in China Indications: Oncology / Endocrinology / Cardiology /CNS
  • Planning and execution for a program including, not limited to, timeline and budget management
  • Management of a cross functional clinical project team as project lead
  • Ensure trial deliverables met timelines, budget, and resources regarding relevant SOPs, ICH
  • Identification of project risks and contingency planning
  • Preparing of study related documents e.g. Study Outline
  • Sourcing and selection of CROs for China studies
  • Leading and conducting negotiations with vendors
  • Review, prepare and negotiate contracts and budgets
Fresenius Kabi Germany / China
onside/remote
3 years
2016-01 - 2018-12

Leading and conducting negotiations with vendors

Contracts Manager (Freelance contract)
Contracts Manager (Freelance contract)
  • Leading and conducting negotiations with vendors
  • Review, prepare and negotiate CDAs, site contracts and budgets with sites / PIs / KOLs
  • Manage budgets
  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites
  • Develop and maintain relationships with KOLs, trial sites, key centers
  • Supporting clinical teams and functions for all their outsourcing needs
IQVIA (Quintiles)
100% remote
7 months
2015-06 - 2015-12

Define RFP specifications and lead the RFP process

Business Manager Oncology (Freelance contract)
Business Manager Oncology (Freelance contract)
  • Leading and conducting negotiations with vendors
  • Define RFP specifications and lead the RFP process
  • Analyse CRO and other study related proposals
  • Serve as Single Point of Contact (SPOC) in assigned indication (oncology) for all vendors
  • Develop and maintain relationships with vendors
  • Supporting clinical teams and functions for all their outsourcing needs, included- but not limited to- negotiating savings, creating contracts of all kinds and delivering training
  • Business and financial risk evaluation and mitigation
  • Preparation of contracts, and negotiate contract terms and conditions and budgets
  • Overseas volume discounts of CROs and ensure cost savings objectives and targets are met
  • Handle on-going issue and change management
  • Evaluate Clinical Development functional or project sourcing specific needs and their impact on the current sourcing strategies, and define how to address these needs
  • Contribute to the implementation of the complete procurement strategy in the Clinical Development area
Roche Pharma AG (Basel)
100% onside
1 year 5 months
2014-01 - 2015-05

Clinical Science Contract Management

  • Lead the negotiation / sourcing process in alignment with the Study Team
  • Serve as Single Point of Contact (SPOC) in assigned indications
  • Develop and maintain relationships with KOLs, PIs, trial sites, and key centers
  • Define RFP specifications and lead the RFP process
  • Analyse CRO and other study related proposals
  • Overseas volume discounts of CROs
  • Ensure cost savings objectives and targets are met
  • Preparation of contracts, and negotiate contract terms and conditions and budgets
  • Review, prepare and negotiate CDAs, contracts and budgets
  • Handle on-going issue and change management
  • Monitor transaction compliance (milestones, deliverables, invoicing etc.)
  • Provide guidance on contract matters to Clinical Study Team
  • Maintain contractual records and documentation tracking tools according SOPs and support ad-hoc requests
Bayer Pharma AG
onside/remote

Aus- und Weiterbildung

Aus- und Weiterbildung

1996 - 2001

Second study of Human Medicine (Zweitstudium der Humanmedizin)

Freie Universität Berlin


06/1998

Promotion

Labor für pharmakologische Biochemie, Schering AG Berlin & Freie Universität Berlin (Dr Thomas Bunte / Prof R. Achazi)


Key Focus:

  • PhD scholarship of Schering AG Berlin
  • Mechanism of ligand independent and - independent interactions of vitamin D receptor and DNA
  • grade: A-Level /sehr gut


10/1995

Animal Physiology, Biochemistry & Molecular Biology, Microbiology

Diplom Biologist, grade: A-Level / sehr gut

Institute of Animal Physiology, Freie Universität Berlin (Prof R. Achazi)


07/1989

staatl. Geprüfte Biol-techn.Assistentin (technian) BTA

Lise-Meitner-Schule Berlin


06/1986

Markgraf-Ludwig-Gymnasium Baden-Baden

Abitur


Scholarships

11/1995 - 03/1998

Promotionsstipendium

(PhD-Scholarship)

Schering AG Berlin


03/1998 - 03/1999

Postdoktorandenstipendium

Schering AG Berlin

Kompetenzen

Kompetenzen

Top-Skills

Clinical Project Management Planning / Setup / Surveillance of Clinical Trials phase I -IV CRO & vendor management outsourcing Clinical Operations Planning Budgeting & Forecasting contract management Regulatory Compliance Good Clinical Practice (GCP) Strategic Sourcing Risk Assessment Problem Solving Easily Adaptable CAR-T Gene therapy Corrective Actions Oncology Cell therapy Study start up Immunology Autoimmune CNS Gastroenterology and Hepatology drug development

Produkte / Standards / Erfahrungen / Methoden

Summary:

  • Freelance clinical research professional qualified by 20+ years in the Pharmaceutical Industry as Clinical Project Manager / Study Manager / Start-up Manager / Contract & Outsourcing Manager.
  • Broad background in clinical trials, drug development, outsourcing, vendor management, project management and R&D. Includes 15+ years experience in Phase I to Phase IV, in the therapeutic areas of Oncology, Immunology, Dermatology, Neurology/CNS and Cell & Gene Therapy (GMO) & Rare (orphan) Diseases.


Skills

  • Management / Coordination of Clinical Trials / Budget Responsibility /Study Lead
  • Planning / Setup / Surveillance of Clinical Trials phase I -IV
  • Hands-on expierence clinical operations management
  • Understanding of regulatory guidelines, GCP requirements
  • Filing Submissions in DACH
  • Profound knowledge in international standards (GCP/ICH), international (FDA/EMEA) and local regulations (China)
  • Site management
  • Development of Clinical Trials Documents
  • Immunology, Dermatology, Neurology/CNS and Cell & Gene Therapy (GMO) & Rare (orphan) Diseases, Biologicals, ATMP
  • Budget and Contract Negotiations with CROs / site contracts / PI contracts
  • CRO & vendor management / outsourcing / RFP / bid meetings / contract management
  • Database systems e.g. Activate, Veena, GoBalto, Triallink, Oracle databases, SQL, Hyperion
  • IVS / IWRS/ Data Management
  • GLP
  • Electronic data capture EDC
  • Ariba, Microsoft Dynamics 365
  • Argos, Credi, NovStyle, COMAS
  • Ability to evaluate and interpret PK data (e.g.WinNonlin)
  • Fluent English language skills
  • Good presentation skills
  • MS Office (Excel, Word, PowerPoint, Project 2000)
  • Medical Terminology

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

13 years 8 months
2011-01 - now

diverse

diverse freelance positions
diverse freelance positions
5 months
2023-04 - 2023-08

Management start-up activities phase

Clinical Project Manager
Clinical Project Manager
  • Management start-up activities phase 2/3 oncology global oncology trials (GMO)
  • Review / prepare of study documents (protocol, eCRF, ICF)
  • Oversee submission process
  • Provide support for answering questions from health authorities
  • Vendor selection and define KPIs
  • Management third party vendors
NDA small biotech company/Munich
100% remote
1 year 2 months
2022-02 - 2023-03

Leading and conducting negotiations with sites

Contract Manager (Freelance contract)
Contract Manager (Freelance contract)
  • Leading and conducting negotiations with sites
  • Review, prepare and negotiate site contracts and budgets with sites / PIs
  • Manage budgets
  • Serve as Single Point of Contact (SPOC) in assigned studies for trial sites
  • Supporting start-up activities and submission processes
PPD / Thermo Fisher
100% remote
1 year 10 months
2020-08 - 2022-05

Leading and conducting negotiations with sites

Senior Trial Capabilities Manager (Freelance contract)
Senior Trial Capabilities Manager (Freelance contract)
  • Leading and conducting negotiations with sites
  • Review, prepare and negotiate site contracts and budgets with sites / PIs
  • Manage budgets
  • Serve as Single Point of Contact (SPOC) in assigned studies for trial sites
  • Supporting clinical teams and functions for all their outsourcing needs
  • Management of BfS submissions
  • From 10/21 performing Start up activities DACH region
  • Submit to RAs / ERBs / ECs
  • Serve as Single Point of Contact (SPOC) to RAs / ERBs / Ecs
  • Involved in planning and preparing Initial Trial Application and amendments
  • Responding queries and collaborates with relevant functions
  • Involved in planning, preparing inform consents
GBS Cork, Eli Lilly Ireland
100% remote
2 years 3 months
2019-01 - 2021-03

Responsible for the management of all start-up

Senior Clinical Project Manager (Freelance contract)
Senior Clinical Project Manager (Freelance contract)
  • Responsible for the management of all start-up aspects of 3 multi-centre, Phase III trials conducted in China Indications: Oncology / Endocrinology / Cardiology /CNS
  • Planning and execution for a program including, not limited to, timeline and budget management
  • Management of a cross functional clinical project team as project lead
  • Ensure trial deliverables met timelines, budget, and resources regarding relevant SOPs, ICH
  • Identification of project risks and contingency planning
  • Preparing of study related documents e.g. Study Outline
  • Sourcing and selection of CROs for China studies
  • Leading and conducting negotiations with vendors
  • Review, prepare and negotiate contracts and budgets
Fresenius Kabi Germany / China
onside/remote
3 years
2016-01 - 2018-12

Leading and conducting negotiations with vendors

Contracts Manager (Freelance contract)
Contracts Manager (Freelance contract)
  • Leading and conducting negotiations with vendors
  • Review, prepare and negotiate CDAs, site contracts and budgets with sites / PIs / KOLs
  • Manage budgets
  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites
  • Develop and maintain relationships with KOLs, trial sites, key centers
  • Supporting clinical teams and functions for all their outsourcing needs
IQVIA (Quintiles)
100% remote
7 months
2015-06 - 2015-12

Define RFP specifications and lead the RFP process

Business Manager Oncology (Freelance contract)
Business Manager Oncology (Freelance contract)
  • Leading and conducting negotiations with vendors
  • Define RFP specifications and lead the RFP process
  • Analyse CRO and other study related proposals
  • Serve as Single Point of Contact (SPOC) in assigned indication (oncology) for all vendors
  • Develop and maintain relationships with vendors
  • Supporting clinical teams and functions for all their outsourcing needs, included- but not limited to- negotiating savings, creating contracts of all kinds and delivering training
  • Business and financial risk evaluation and mitigation
  • Preparation of contracts, and negotiate contract terms and conditions and budgets
  • Overseas volume discounts of CROs and ensure cost savings objectives and targets are met
  • Handle on-going issue and change management
  • Evaluate Clinical Development functional or project sourcing specific needs and their impact on the current sourcing strategies, and define how to address these needs
  • Contribute to the implementation of the complete procurement strategy in the Clinical Development area
Roche Pharma AG (Basel)
100% onside
1 year 5 months
2014-01 - 2015-05

Clinical Science Contract Management

  • Lead the negotiation / sourcing process in alignment with the Study Team
  • Serve as Single Point of Contact (SPOC) in assigned indications
  • Develop and maintain relationships with KOLs, PIs, trial sites, and key centers
  • Define RFP specifications and lead the RFP process
  • Analyse CRO and other study related proposals
  • Overseas volume discounts of CROs
  • Ensure cost savings objectives and targets are met
  • Preparation of contracts, and negotiate contract terms and conditions and budgets
  • Review, prepare and negotiate CDAs, contracts and budgets
  • Handle on-going issue and change management
  • Monitor transaction compliance (milestones, deliverables, invoicing etc.)
  • Provide guidance on contract matters to Clinical Study Team
  • Maintain contractual records and documentation tracking tools according SOPs and support ad-hoc requests
Bayer Pharma AG
onside/remote

Aus- und Weiterbildung

Aus- und Weiterbildung

1996 - 2001

Second study of Human Medicine (Zweitstudium der Humanmedizin)

Freie Universität Berlin


06/1998

Promotion

Labor für pharmakologische Biochemie, Schering AG Berlin & Freie Universität Berlin (Dr Thomas Bunte / Prof R. Achazi)


Key Focus:

  • PhD scholarship of Schering AG Berlin
  • Mechanism of ligand independent and - independent interactions of vitamin D receptor and DNA
  • grade: A-Level /sehr gut


10/1995

Animal Physiology, Biochemistry & Molecular Biology, Microbiology

Diplom Biologist, grade: A-Level / sehr gut

Institute of Animal Physiology, Freie Universität Berlin (Prof R. Achazi)


07/1989

staatl. Geprüfte Biol-techn.Assistentin (technian) BTA

Lise-Meitner-Schule Berlin


06/1986

Markgraf-Ludwig-Gymnasium Baden-Baden

Abitur


Scholarships

11/1995 - 03/1998

Promotionsstipendium

(PhD-Scholarship)

Schering AG Berlin


03/1998 - 03/1999

Postdoktorandenstipendium

Schering AG Berlin

Kompetenzen

Kompetenzen

Top-Skills

Clinical Project Management Planning / Setup / Surveillance of Clinical Trials phase I -IV CRO & vendor management outsourcing Clinical Operations Planning Budgeting & Forecasting contract management Regulatory Compliance Good Clinical Practice (GCP) Strategic Sourcing Risk Assessment Problem Solving Easily Adaptable CAR-T Gene therapy Corrective Actions Oncology Cell therapy Study start up Immunology Autoimmune CNS Gastroenterology and Hepatology drug development

Produkte / Standards / Erfahrungen / Methoden

Summary:

  • Freelance clinical research professional qualified by 20+ years in the Pharmaceutical Industry as Clinical Project Manager / Study Manager / Start-up Manager / Contract & Outsourcing Manager.
  • Broad background in clinical trials, drug development, outsourcing, vendor management, project management and R&D. Includes 15+ years experience in Phase I to Phase IV, in the therapeutic areas of Oncology, Immunology, Dermatology, Neurology/CNS and Cell & Gene Therapy (GMO) & Rare (orphan) Diseases.


Skills

  • Management / Coordination of Clinical Trials / Budget Responsibility /Study Lead
  • Planning / Setup / Surveillance of Clinical Trials phase I -IV
  • Hands-on expierence clinical operations management
  • Understanding of regulatory guidelines, GCP requirements
  • Filing Submissions in DACH
  • Profound knowledge in international standards (GCP/ICH), international (FDA/EMEA) and local regulations (China)
  • Site management
  • Development of Clinical Trials Documents
  • Immunology, Dermatology, Neurology/CNS and Cell & Gene Therapy (GMO) & Rare (orphan) Diseases, Biologicals, ATMP
  • Budget and Contract Negotiations with CROs / site contracts / PI contracts
  • CRO & vendor management / outsourcing / RFP / bid meetings / contract management
  • Database systems e.g. Activate, Veena, GoBalto, Triallink, Oracle databases, SQL, Hyperion
  • IVS / IWRS/ Data Management
  • GLP
  • Electronic data capture EDC
  • Ariba, Microsoft Dynamics 365
  • Argos, Credi, NovStyle, COMAS
  • Ability to evaluate and interpret PK data (e.g.WinNonlin)
  • Fluent English language skills
  • Good presentation skills
  • MS Office (Excel, Word, PowerPoint, Project 2000)
  • Medical Terminology

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