Recommended expert

Jessica Cordes

Clinical Operations | AI Transformation

Jessica Cordes
Munich, Germany

Experience

Nov 2023 - Present
2 years 4 months
Munich, Germany

Senior Consultant and Trainer

Clinical Excellence GmbH

Jul 2022 - Oct 2023
1 year 4 months
Munich, Germany

Global Head of Clinical Operations (Senior Director, Clinical Operations)

Immatics Biotechnologies GmbH

  • Drug type: cell and gene therapy (ATMPs) with TCR products and bispecific products
  • Overseeing phase I/II clinical trials in solid tumor baskets with T cell products and bispecific products
Jan 2021 - Jun 2022
1 year 6 months
Munich, Germany

Head of Clinical Operations

Immatics Biotechnologies GmbH

  • Drug type: cell and gene therapy (ATMPs) with TCR products and bispecific products
  • Overseeing phase I/II clinical trials in solid tumor baskets with T cell products and bispecific products
  • Building a global Clinical Operations department (incl. structure, team, culture and processes)
  • Line management and employee development of Clinical Operations resources 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 for Clinical Operations activities
  • Vendor governance
  • Implementing Key Performance Indicators and clinical trial scorecard
  • Optimizing patient recruitment through a patient engagement program
  • Staff recruiting strategy for Clinical Operations
  • Selecting vendors (CROs, central labs, and others)
  • Implementing a culture of continuous process improvement for Clinical Operations
  • Review of current and development of new SOPs (process optimization project)
  • Ensuring processes compliant with GCP and ATMP-specific regulations, guidelines, and laws
  • QA support during audits
Jan 2018 - Dec 2020
3 years
Planegg, Germany

Director, Clinical Operations (Head of Clinical Operations)

Medigene AG

  • Drug type: cell and gene therapy (ATMPs), incl. TCR and DC products
  • Working on phase I/II clinical trial in Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM)
  • Oversight of all Clinical Operations activities
  • Line management and employee development of Clinical Operations resources, including home-based positions
  • Global clinical operational input into clinical development plans
  • Budget planning and controlling for Clinical Operations
  • Implementing an outsourcing strategy for Clinical Operations activities
  • Vendor governance
  • Implementing Key Performance Indicators and CRO scorecard
  • Optimizing patient recruitment through a patient engagement program
  • Staff recruiting strategy for Clinical Operations
  • Selecting vendors (CROs, central labs, and others)
  • Implementing a culture of continuous process improvement for Clinical Operations
  • Review of current and development of new SOPs (process optimization project)
  • Ensuring processes compliant with GCP and ATMP-specific regulations, guidelines, and laws
  • Hands-on Clinical Trial Management for Phase I/II clinical trial
  • QA support during audits
  • Collaboration with the German Association of Pharmaceutical Development Companies
Jan 2017 - Dec 2017
1 year
Planegg, Germany

Associate Director, Clinical Development (Clinical Trial Manager)

Medigene AG

  • Drug type: cell and gene therapy (ATMPs), incl. TCR and DC products
  • Working on phase I/II clinical trial in Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM)
  • Responsibility for international clinical trial management (incl. set-up, monitoring, and close-out)
  • Clinical trial set-up: feasibility evaluation, protocol discussion, vendor selection, investigator selection, investigator contract negotiations, baseline budgeting, patient insurance, submission to the ethics committee and regulatory authority (PEI), set-up of clinical trial-specific documents and systems
  • Clinical trial execution and monitoring: responsibility for consistency with design, implementation, and timelines of clinical trial deliverables; communication and coordination of needed actions and timelines for internal and external functional units; vendor oversight; monitoring of patient recruitment, protocol deviations, and data queries; budget control (incl. accruals); coordination of resources and resolution of conflicts
  • Selecting vendors (e.g. CROs, central labs, and others)
  • Review of current and development of new SOPs (process optimization project)
  • Collaboration with the German Association of Pharmaceutical Development Companies
Jan 2015 - Dec 2016
2 years
Planegg, Germany

Senior Manager, Clinical Operations (Clinical Trial Leader)

MorphoSys AG

Jan 2014 - Dec 2014
1 year
Planegg, Germany

Manager, Clinical Operations (Clinical Trial Leader)

MorphoSys AG

May 2013 - Dec 2013
8 months
Planegg, Germany

Clinical Trial Leader

MorphoSys AG

  • Drug type: antibodies
  • Working on phase I/II clinical trial in Multiple Myeloma and Investigator-Initiated Trial in Chronic Lymphocytic Leukemia (CLL)
  • Responsibility for international clinical trial management (incl. set-up, monitoring, and close-out)
  • Clinical trial set-up: feasibility evaluation, protocol discussion, vendor selection, investigator selection, investigator contract negotiations, baseline budgeting, patient insurance, submission to the ethics committee and regulatory authority (PEI), set-up of clinical trial-specific documents and systems, IMP demand planning
  • Clinical trial execution and monitoring: responsibility for consistency with design, implementation, and timelines of clinical trial deliverables; communication and coordination of needed actions and timelines for internal and external functional units; vendor/CRO oversight; monitoring of patient recruitment, protocol deviations, and data queries; budget control (incl. accruals); coordination of resources and resolution of conflicts
  • Line management responsibilities for a team (Clinical Trial Administrators, Clinical Research Associates)
  • Review of current and development of new SOPs (process optimization project)
  • Due diligence of products with in-licensing potential (project team member)
  • Purchase order system implementation (project team member)
  • Evaluating benchmarking systems
  • QA support during audits
Mar 2009 - Apr 2013
4 years 2 months
Hamburg, Germany

Project Leader

GlaxoSmithKline GmbH & Co.KG

  • Drug type: Chemicals
  • Working on phase II-IV clinical trials (benign prostate hyperplasia (BPH), gastrointestinal disease, chronic obstructive pulmonary disease (COPD))
  • Responsibility for clinical trial management in Germany (incl. clinical trial set-up, monitoring, and close-out)
  • Clinical trial set-up: feasibility investigator selection, budgeting, patient insurance, submission to the ethics committee and regulatory authority (BfArM), set-up of clinical trial-specific documents, providing clinical trial training to team members, training at investigator/monitor meetings, supportive actions for patient recruitment (e.g. advertisement)
  • Clinical trial execution and monitoring: responsibility for consistency with design, implementation, and timelines of clinical trial deliverables; communication and coordination of needed actions and timelines for internal and external functional units; budget control; coordination of resources and resolution of conflicts
  • Clinical trial close-out: coordination of data cleaning, collection of clinical trial documents, communication of clinical trial termination (ethics committee, regulatory authority, investigators)
  • Implementation of Lean Six Sigma in ongoing clinical trials
  • Review of current and development of new SOPs
  • QA support during audits
Mar 2007 - Feb 2009
2 years
Hamburg, Germany

Project Leader

MDS Pharma Services Central Lab GmbH

  • Working on phase II-IV clinical trials (Diabetes, Epilepsy, Dermatology)
  • Responsibility for overall clinical trial management (incl. set-up and validation of clinical software database, trial monitoring and close-out, presentation/workshop at investigator, monitor and client meetings)
  • Responsibility for consistency with design, implementation, and timelines of clinical trial deliverables based on budget expectations
  • Set of clinical trial-specific documents for the Central Lab part
  • Communication and coordination of timelines for internal and external functional units
  • Coordination of resources and resolution of conflicts
  • Participation in the process of new bids and change requests
  • Personnel training within the clinical trial team by conducting meetings and providing coaching to team members
  • Review of current and development of new SOPs
  • QA support during audits
Oct 2006 - Feb 2007
5 months
Lübeck, Germany

Research Associate

University of Lübeck

  • Structural analysis of pathogen-host interactions

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (15.5 years), Biotechnology (11 years), Healthcare (5 years), Professional Services (2.5 years), and Education (0.5 years).

Pharmaceutical
Biotechnology
Healthcare
Professional Services
Education

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Research and Development (14 years), Quality Assurance (13.5 years), Project Management (12.5 years), Operations (6 years), and Human Resources (2.5 years).

Research and Development
Quality Assurance
Project Management
Operations
Human Resources

Summary

A Clinical Operations expert with more than 15 years experience in clinical research, including 8 years in hemato-oncology, 6 years in the ATMP area, and 2 years in solid tumors. A self-motivated enthusiast who brings a collaborative spirit into the team and drives company goals and innovation.

Skills

  • International And Country Clinical Operations Experience

  • Line Management Experience (On-site And Remote)

  • Strong Skills In Building The Clinical Operations Department (I.e. Structure, Team, Processes)

  • Strong Skills In Team Building And Change Management (On-site And Remote)

  • Training In Ich-gcp, Including Atmp Guidelines

  • Strong Skills In Project Management And Communication

  • Training In Lean Sigma (White Belt)

  • Training In Scrum (Disciplined Agile Scrum Master By Project Management Institute)

  • Ms Office 365, Incl. Ms Project, Ms Sharepoint, Ms Teams

  • Purchase Ordering Systems: Sap Cerps, Windows Ax, Business Central

Languages

German
Native
English
Advanced
French
Elementary

Education

Oct 2004 - Sep 2006

University of Lübeck

Master of Science, Cell biology and Structural biology · Molecular Life Science · Lübeck, Germany · CPA: 2.0 (good)

Oct 2001 - May 2004

University of Lübeck

Bachelor of Science · Molecular Biotechnology · Lübeck, Germany · CPA: 2.6 (satisfactory)

Sep 1995 - Jul 2001

Gymnasium Salzgitter Bad

Secondary School · Salzgitter, Germany

Certifications & licenses

Manager for applied AI Transformation

TÜV Rheinland

Disciplined Agile Scrum Master

Project Management Institute

Lean Sigma White Belt

Profile

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Jessica based?

Jessica is based in Munich, Germany and prefers 100% remote projects.

What languages does Jessica speak?

Jessica speaks the following languages: German (Native), English (Advanced), French (Elementary).

How many years of experience does Jessica have?

Jessica has at least 19 years of experience. During this time, Jessica has worked in at least 10 different roles and for 7 different companies. The average length of individual experience is 2 years and 9 months. Note that Jessica may not have shared all experience and actually has more experience.

What roles would Jessica be best suited for?

Based on recent experience, Jessica would be well-suited for roles such as: Senior Consultant and Trainer, Global Head of Clinical Operations (Senior Director, Clinical Operations), Head of Clinical Operations.

What is Jessica's latest experience?

Jessica's most recent position is Senior Consultant and Trainer at Clinical Excellence GmbH.

What companies has Jessica worked for in recent years?

In recent years, Jessica has worked for Clinical Excellence GmbH and Immatics Biotechnologies GmbH.

Which industries is Jessica most experienced in?

Jessica is most experienced in industries like Pharmaceutical, Biotechnology, and Healthcare. Jessica also has some experience in Professional Services and Education.

Which business areas is Jessica most experienced in?

Jessica is most experienced in business areas like Research and Development (R&D), Quality Assurance (QA), and Project Management. Jessica also has some experience in Operations and Human Resources (HR).

Which industries has Jessica worked in recently?

Jessica has recently worked in industries like Healthcare, Biotechnology, and Pharmaceutical.

Which business areas has Jessica worked in recently?

Jessica has recently worked in business areas like Quality Assurance (QA), Operations, and Research and Development (R&D).

What is Jessica's education?

Jessica holds a Master in Molecular Life Science from University of Lübeck and a Bachelor in Molecular Biotechnology from University of Lübeck.

Does Jessica have any certificates?

Jessica has 3 certificates. These include: Manager for applied AI Transformation, Disciplined Agile Scrum Master, and Lean Sigma White Belt.

What is the availability of Jessica?

Jessica is immediately available for suitable projects.

What is the rate of Jessica?

Jessica's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.

How to hire Jessica?

To hire Jessica, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

Rates are based on recent contracts and do not include FRATCH margin.

1200
900
600
300
Market avg: 850-1010 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.