Freelancer profile translated to English.
Back to original languageAbout Jessica
I am a Clinical Operations Leader with
- over 15 years of professional experience in Clinical Operations
- over 12 years in Oncology
- over 12 years of people management, including over 6 years in departmental leadership
- over 6 years in Cell and Gene Therapies
- TÜV certified as Manager for Applied AI Transformation
In 2023, I became self-employed as a Senior Consultant with Clinical Excellence GmbH.
My Experience:
As Head of Department, I built a global Clinical Operations team where team members worked in the office and remotely.
Here, I recruited team members in Germany and the USA, both on-site and remotely, conducted onboarding, and fostered a globally aligned team mentality.
Additionally, I optimized processes to:
- improve GCP compliance/inspection readiness
- increase efficiency and effectiveness in Clinical Operations
- conduct ATMP studies
- prepare for 'late stage' clinical studies
As a Clinical Project Manager, I selected and supervised study sites and service providers, ensured the timely setup of clinical studies, and planned and monitored the budget for clinical studies.
Here, I collaborated effectively with interdisciplinary teams to:
- plan clinical studies
- implement processes and documentation for clinical studies
- conduct clinical studies according to GCP, timeline, and budget
- complete clinical studies
German
Native or bilingual
Remote only
Primarily works remotely
Experience
- the Clinical Excellence GmbHSenior Consultant and TrainerNovember 2023 - Today (2 years and 7 months)Munich, GermanyFunction: Senior Consultant and Trainer at the Clinical Excellence GmbH, Munich, Germany
- the Immatics Biotechnologies GmbHGlobal Head of Clinical OperationsJuly 2022 - October 2023 (1 year and 3 months)Munich, GermanyDrug type: cell and gene therapy (ATMPs) with TCR products bispecific products Overseeing phase I/II clinical trials in solid tumor baskets with T cell products and bispecific products
- the Immatics Biotechnologies GmbHHead of Clinical OperationsJanuary 2021 - June 2022 (1 year and 5 months)Munich, GermanyDrug type: cell and gene therapy (ATMPs) with TCR products bispecific products Overseeing phase I/II clinical trials in solid tumor baskets with T cell products and bispecific productsKey Responsibilities:• Building a global Clinical Operations department (incl. structure, team, culture and processes)• Line management and employee development of Clinical Operations resources (country Heads of Clinical Operations, diverse Group Leaders, Clinical Operations Leads, Site Operations Leads, Clinical Trial Managers, Sampling Oversight Managers, Clinical Research Associates, Clinical Trial Administrators, Clinical Data Manager, Clinical Outsourcing Manager, Document Control Specialists) in Germany and USA, including home-based positions.• Oversight of all Clinical Operations activities and the delivery of company goals• Global clinical operational input into clinical development plans• Budget planning and controlling for Clinical Operations• Implementing an outsourcing strategy of Clinical Operations activities• Vendor governance• Implementing Key Performance Indicators and clinical trial scorecard• Optimizing patient recruitment by a patient engagement programme
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Education
- Master of ScienceUniversity of Lübeck2006Masters Course in Molecular Life Science
- Bachelors Course in Molecular BiotechnologyUniversity of Lübeck2004Bachelors Course in Molecular Biotechnology
Certifications
- Manager for Applied AI TransformationTÜV Rheinland