Clinical Project Manager

Duration: 40 CPD Hours

The role of a clinical project manager involve the following:

May be assigned at drug discovery during the early stages of clinical trials and work on developing the Clinical Protocol and setting up the clinical phase of the study (early Pharmacokinetic Studies), or may be assigned to Phase II-IV studies (for example Safety & Efficacy, Overall Survival or Post marketing/Observational/Investigator led studies).

Work with members of the project team (Clinical Research Associates, Study Team Leads, Medical Monitors, Regulatory, Data Management, Pharmacokinetics, Statistics, Commercial and Marketing) , identifying issues that might delay the project and making recommendations to improve time lines for project completion.

Oversee the feasibility of studies and establish relationships with Key Opinion Leaders.

Often present at Investigator Meetings and for a CRO are the key leaders for running a clinical project that has been outsourced by a Client to them.

Manage budget and finance management will also depend on the organization.

Involved in identifying any risks and managing these.

May often conduct oversight visits to Investigator sites with Clinical Research Associates.

Compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data. Clinical Project Managers are responsible for the budget of a clinical trial and ensuring that all expectations are met regarding costing of the study.

May or may not be therapeutically aligned.

Course description:

Designed for those that have experience in the field of clinical research (BSc or Post Graduate qualification required- Nursing or Science). Following completion of this course you will be able to collaborate with Directors on Global Project Operations and Directors in Business Development. You will have gained to knowledge of international regulatory frameworks as they relate to clinical requirements for product registration, a strong understanding of corporate and operational business issues as well as understanding project planning issues, budgeting, priority setting and key project management skills. Estimated completion time 40 hours on-line.

This course is comprehensive which covers the following elements. At the end of the course you will be presented with a certificate and a link to forward your CV for modification and support for future job applications:

• Good Clinical Practice
• Phase I Clinical Studies
• Phase II-IV Clinical Studies
• Pharmaceutical Industry and Outsourcing
• Essential Documents
• Protocol, Investigators Brochure and Case Record Form
• Clinical Study Monitoring Plan
• Regulatory Affairs (IND & Regulatory Submissions)
• Ethics Committees & Submission process EU/IRB's Submission process
• Adverse and Serious Adverse Events
• Investigator and Site responsibilities
• Informed consent process
• Role of Clinical Research Associate/Clinical Project Manager

Tasks for Clinical Project Manager Training:

• Training for a Clinical Project Manager
• Statistical Plan
• Data Management Plan
• Investigational Product Plan
• Clinical Management Plan
• Managing risk
• Managing budgets
• Setting up studies globally
• Preparing for Investigator meetings
• Key elements for study delay
• Recruitment issues

more....

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