Introduction

As CRA fellows accumulate experience in the clinical study industry, they will more or less start to think about their personal career plans. For the CRA career, there are many development paths to follow, such as personnel management, project management, quality management, training, pharmacovigilance, BD, etc. However, many CRA will take "project management" as the next growth goal in their career.

In this episode, we are honored to invite May, the Clinical Trial Director, to share her thoughts on how CRA can turn into PM. We hope that the contents in this episode will show fellows striving in the front-line clinical study a path to project management.

Let's start by clarifying a few concepts about "projects".

What is a project?

A project is a temporary job to create unique products, services and results.

What is project management?

Project management refers to the process of applying specialized knowledge, skills, tools and methods required in the project activities to enable projects to meet or exceed set needs and expectations with limited resources.

The elements of project management include: Scope, progress, cost, quality, risk, procurement, resources, communication, and interested parties. What does a project manager do? The project manager's job is to define the team's scope of work, progress, cost, quality etc., and to lead and manage the project team to carry out the project smoothly, ensuring that the clinical trial protocol is implemented correctly and the project results are delivered according to the expected objectives.

The project manager is required to manage the project in a holistic manner under multiple constraints, to advance the project in an orderly way according to the project plan with limited costs, resources and established project scope, and ultimately to make client satisfy with the deliverables and process.

What does project management in a clinical trial include? From the perspective of the life cycle of a clinical trial project, it mainly includes 5 major elements:

-Initiation process: Project assessment, project establishment and budgeting;

-Planning process: Scope of work determination, project team setup, core project documents determination, project plan formulation, project-applicable SOPs determination, initial internal and external project meetings convening, etc.;

-Implementation and monitoring process: Project training implementation, list of participating sites determination, investigator meetings/protocol workshops convening, completion of building/launching of systems used in the project, completion of pre-launch site preparation, site launching, visits monitoring, TMF management, communication management, risk management, safety information reporting and management, protocol deviation management, progress management and reporting, project milestone achievement/adjustment, budget management, team management (including vendor management), briefing writing, Q&A Log maintenance, data cleanup/lockup, site closure, summary report, etc.;

- Closing process: Project documents handover, financial closure, system accessibilities closure, lessons, summary, etc.

Unlike the CRA, who acts as the manager of study sites, the project manager needs to make plans and manage all aspects of the project in an integrated manner. For CRA who wants to grow into project manager in the future, he/she should continue to expand their knowledge base, improve their capabilities, become a diligent learner, and make full use of available learning resources.

The following are 2 effective learning methods based on my personal experience: Firstly, you can get project management knowledge through authoritative open courses on Wechat or attend systematic project manager training etc. to help build project management and knowledge frameworks, understand the whole process of project management, and master project management methods. Secondly, you can learn from excellent PMs around you with sharp eyes in terms of their good understanding of regulations, outstanding English, beautiful and logical slides, high communication efficiency, high stress tolerance, etc. Through these observations and understanding, you can regard such excellent project managers as benchmarks, carefully consider the abilities and personalities that make them so excellent, and develop your own learning plans accordingly.

Lastly, it is recommended that you have a sense of active learning. The following are 5 aspects that require continuous learning summarized in my daily work.

1.Gain extensive medical knowledge in various therapeutic areas, but not limited to the diagnosis and treatment of common diseases.

2.Read intensively industry-related regulations, not only limited to GCP, but also including safety evaluation, drug registration management methods, human genetic resources management methods, etc.

3.Follow and understand industry information, including some cutting-edge treatments, industry trends, etc.

4.Improve continuously soft skills such as writing skills, presentation skills, English proficiency, communication skills, problem solving skills, emotion management, goal management, time management, conflict management skills, etc.

5.Understand the scope of responsibilities and workflow of various departments related to clinical trials such as data management, pharmacovigilance, medicine, statistics, etc. to facilitate professional communication across departments/ functions, clarify the scope of responsibilities and mobilize resources to control the project progress.

A good project manager makes a clear division of labor and consistent goals in all parts of the project. A project manager does not have to be an expert in each functional area of expertise, but must know the owner of each task, provided that he/she has a good understanding of job responsibilities of each department.

All of these aspects in my opinion are worthy of repeated reflective learning, and one of the effective ways to learn is to take the initiative to undertake work outside the scope of his/her duties whenever possible. Every CRA wants to meet a professional, good-attitude, efficient and responsible project manager. We can try to assume ourselves to be such a "perfect" project manager in mind, and work towards this goal.

Finally, I sincerely wish CRAs striving in the field of clinical research to achieve a gorgeous transition soon.

As it is another graduation season, we have inserted an advertisement at the end of this article. Welcome to join the technology-enabled full service CRO. Elixir Clinical Research welcomes aspiring people in different fields from all over the world. There are like-minded fellows here, there is also a platform for you to show your talent and ambition. We look forward to working together with you and writing a beautiful chapter.

How to Join Us?

Please send your resume to the following email address:

sfrecruit@mobilemd.cn

Email subject:

Job title-City-Applicant name

Come and submit your resume!

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