2025-04-25 2025-04-25 , online online, 0 € zzgl. MwSt. Dr. Anna Christina Hörster, PMP https://forum-institut.de/seminar/25102104-clinical-trial-project-management/referenten/25/25_10/25102104-seminar-online-clinical-trial-project-management_hoerster,-pmp-anna-christina.jpg Clinical Trial Project Management

This seminar offers beginners in clinical project management the opportunity to gain comprehensive insight into their responsibilities as clinical project managers and to acquire both specialized project management knowledge and skills in team leadership and communication.

Topics
  • Project management tools, project plans and documentation
  • Setting up a project baseline - study planning
  • Service provider and study site management
  • Conducting and surveillance of the clinical trial: ressources, budget, quality & safety
  • Managing the "people-business" - skills and methods
  • Project close-out, learnings and improvement processes


Who should attend
The seminar is specifically designed for project managers in clinical or medical affairs, who would like to learn the basics of clinical trial project management.

Especially those who have recently taken on project responsibility in clinical trials or who aspire to work as a clinical project manager will benefit from the knowledge imparted. Basic knowledge of clinical trials is a prerequisite.

This course will be conducted in English.
Aims and objectives
Project management in clinical trials is complex. A project manager must possess extensive technical knowledge to effectively oversee clinical studies from planning through to completion, as well as master the people skills necessary to ensure successful collaboration within the study team.

This seminar offers you both - specialized knowledge in clinical project management as well as essential competencies for team management.

You will become familiar with the documents and measures that are used to steer and monitor clinical trials. You will understand the tasks assigned to you as a project manager during the various project stages of clinical trials. And you will learn how to ensure throughout the entire project duration that quality, data integrity, and budget compliance are maintained.
Your benefit

After the seminar, you will

  • be familiar with the wide range of responsibilities associated with the role of a project manager in clinical trials.
  • understand which documents need to be created, maintained, and monitored within the scope of project management.
  • be capable of performing your practical tasks related to the planning, conduction, and surveillance of clinical trials.
  • have gained an appreciation of the importance of aspects beyond purely technical PM-expertise, such as team leadership and communication.

Online-Seminar - Clinical Trial Project Management

Clinical Trial Project Management

Skills, Tools, and Methods for Successful Clinical Trials

Benefits
  • Managment skills from concept to completion of the clinical trial
  • Technical PM-expertise, team leadership & communication skills
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25102104

Jetzt buchen

JETZT Buchen
Referenten

Dr. Anna Christina Hörster, PMP

Advanced Clinical GmbH, Frankfurt

Senior Director, Project Management
More information please click here.

Dr. Marco Schwarzer

Sino Consultancy, Falkensee

Managing Director

Alles auf einen Blick

Termin

07-08/10/2025

07-08/10/2025

Zeitraum

Veranstaltungsort

online

online

Downloads
Abbreviation list Clinical Research
Abbreviation list Clinical Research
Gebühr

Veranstaltung - 0 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Veranstaltung - 0 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Regine Görner
Dr. Verena Klüver

r.goerner@forum-institut.de
v.kluever@forum-institut.de

Details

This seminar offers beginners in clinical project management the opportunity to gain comprehensive insight into their responsibilities as clinical project managers and to acquire both specialized project management knowledge and skills in team leadership and communication.

Topics

  • Project management tools, project plans and documentation
  • Setting up a project baseline - study planning
  • Service provider and study site management
  • Conducting and surveillance of the clinical trial: ressources, budget, quality & safety
  • Managing the "people-business" - skills and methods
  • Project close-out, learnings and improvement processes


Who should attend
The seminar is specifically designed for project managers in clinical or medical affairs, who would like to learn the basics of clinical trial project management.

Especially those who have recently taken on project responsibility in clinical trials or who aspire to work as a clinical project manager will benefit from the knowledge imparted. Basic knowledge of clinical trials is a prerequisite.

This course will be conducted in English.

Aims and objectives

Project management in clinical trials is complex. A project manager must possess extensive technical knowledge to effectively oversee clinical studies from planning through to completion, as well as master the people skills necessary to ensure successful collaboration within the study team.

This seminar offers you both - specialized knowledge in clinical project management as well as essential competencies for team management.

You will become familiar with the documents and measures that are used to steer and monitor clinical trials. You will understand the tasks assigned to you as a project manager during the various project stages of clinical trials. And you will learn how to ensure throughout the entire project duration that quality, data integrity, and budget compliance are maintained.

Your benefit

After the seminar, you will

  • be familiar with the wide range of responsibilities associated with the role of a project manager in clinical trials.
  • understand which documents need to be created, maintained, and monitored within the scope of project management.
  • be capable of performing your practical tasks related to the planning, conduction, and surveillance of clinical trials.
  • have gained an appreciation of the importance of aspects beyond purely technical PM-expertise, such as team leadership and communication.

Programm

Dr. Anna Christina Hörster, PMP

Project management principles
  • Clinical project management and its challenges
  • Project life cycle
  • Clinical project management roles and responsibilities
    • The project manager as key figure and its qualifications
    • Organizing the project team: decision-making levels, authority, delegation
  • Portfolio and programme management - similarities and differences

Dr. Anna Christina Hörster, PMP

Clinical project management tools and documentation
  • Project planning tools: what to use?
  • Project management plan
  • Clinical trial protocol
  • Risk management and contingency plan

Setting up a project baseline - study planning
  • Estimation of time and cost
    • Budget calculation
    • Planning work packages/activities based on the project management plan
  • Defining milestones and deadlines
  • Calculating the critical path

Service provider and study site management
  • CRO selection, contracts and QA agreements
  • Investigator and site selection
  • Patient recruitment challenges, patient information and initiation of the study sites

Conducting and surveillance of the clinical trial
  • Contact with authorities and ethics committees
  • Project evaluation
    • Metrics/analyses and interpretation of trial data
    • Countermeasures in case of imbalance
  • Resource and budget control; tolerance limits for deviations
  • Quality management (including audits/inspections)
  • Safety
  • Reporting procedures

Managing the "people-business" - skills and methods
  • "Good Communication Practice" within the team
  • Teamwork and motivation
  • Conflict management

Project close-out and completion of the clinical trial
  • Closing study sites
  • Data clearing and statistical evaluation
  • Final documentation and archiving
  • Project results management, publication
  • Learning from failures and improvement processes

Further information

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

This distinguishes our events

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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