A project manager is a person who is responsible for the successful planning, design, execution,
monitoring, controlling and closure of a project. Their main role is to come up with solutions or approaches that facilitate the commercialization of that particular brand or product. This job title is present in many different industries such as construction, petrochemical, architecture, information technology.

On the other hand, The role of a clinical project manager is to ensure that the clinical research projects are in compliance with protocols and overall clinical objectives. They basically plan and coordinate clinical research projects. In addition to evaluation and analyses of the clinical data. For instance, they assess the eligibility of potential subjects through the screening interviews after reviewing their medical records, and discussing with the physicians or nurses.

In my point of view both does has same responsibilities. I don't find any difference between Project Manager and Clinical Project Manager. Clinical refers to the domain in which he is involved to handle the project. Let's consider a Software Project Manager. He does the same work what a Clinical Project Manager does. A software project manager considers the strategy, tactics, endurance in the application of a software and looks into various criteria that are necessary for the implementation and promotion of a particular software development. In the same way Clinical project manager considers the same strategy, tactics, endurance in the application of a medical device or a drug and look into various criteria that are necessary for the successful promotion of a particular device or a drug. Both have the same responsibilities in their own field. Software project manager deals with the world of Software and codes. Clinical project manager deals with the world of medical devices and humans. This is applicable to all fields. So both of them aren't different.

Although both have similar end goals, mainly that of ensuring successful completion of a project. I agree with Shachi in that there is a significant difference between the two. Project manager is more of a broad term which can refer to any industry and not specifically medical devices. A clinical project manager on the other hand deals with medical devices, pharmaceuticals, drug trials, etc. They directly deal with ensuring clinical research/trials are conducted properly and analyze clinical data/outcomes. Therefore, a clinical project manager is a more specific subdivision of a broad category referred to as project managers, which can be in many different industries. This is why both would be considered different.

I think that they are very similar in the role developed, with the only difference that a project manager covers any project. For example: he/she could lead and execute the construction of a building or the development of a new medical device (depending on the specialty of the engineer). On the other hand, a clinical project manager is more narrowed. It is limited to leading and executing projects in the laboratory. I would say that clinical project managing is just a branch of project manager. They both cover the same concept because they are about leading and executing different types of projects.

I tend to agree with kpr76 and Roberto Pineda here when they conclude that they are different in function yet noticeably similar in their overall end goals. The occupation “project manager” is a broad term that is used across the scientific and construction community to name somebody who is in charge of the overall result of the project. This project could pretty much encompass anything that involves coordinating multiple people/ groups together and supervising the progress to the overall end product. Both pay extremely close attention to the needs and progress of their staff while guiding them in the desired direction of the overall project. This differs compared to a clinical project manager who is restricted primarily to laboratory/ medical settings. Clinical project managers deal primarily with monitoring study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Also, they record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. It is this attention to the medical improvement/well-being of their patients which makes the clinical project manager a uniquely specialized subdivision of the project manager title.

More: http://www.pharmiweb.com/Features/feature.asp?ROW_ID=1635#.WItzvfkrKM8#ixzz4WzszDGJl

I agree with Krp, Pineda and dag56' posts. I would like to add that although they are similar in the main functionality, I would say a broader project manager is going to face a harder time getting accustomed to all the clinical details and rules. As dag56 mentions, a clinical project manager is a more of a unique I would say more specialized and advantageous in the clinical division.

Hello,

There are great points made above. I agree with the aspect of their similarity in terms of being responsible for the completion of projects in a timely manner. Organizing individuals, delegating responsibilities and coordinating schedules. However, as mentioned by our classmates, the term project manager can apply to a wide variety of fields throughout industry. Additionally, they may be responsible for different functional areas. One may manage engineering, another marketing, sales etc. A clinical PM is a type of specialized PM that has a focus in the clinical aspect of a project. Their focus is on the lab, tests and data collection to further the project. However, in many real world situations this responsibility typically spills over to include other aspects across other fields.

-Romany Botros

I believe the two positions are quite similar in a lot of ways. I see the clinical pm as a subset of project managers as a whole. According to progenics pharmaceuticals, these are the primary responsibilities of a CPM:

-Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.
-Serves as primary contact and resource for LCRA, CRO and vendor personnel. Supports selection and provides oversight and management of CROs, consultants and vendors.
-Tracks and reports on the progress of assigned clinical trials including budget and timelines.
Preparation, oversight and review of study related documents.
-Works with Clinical Trial Managers, Data Management, Clinical Trial Assistant and Document Control Specialist to create and manage study related documents.
-Co-monitors with CRO’s Monitors to evaluate and ensure quality of CRO Monitoring Team. Ensures that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs.
-Organizes (or assists with organizing) and participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and CRO Training.
-Participate in the preparation, review, updating and training of SOPs.

I believe the main difference that distinguishes CPM's from other project managers is the amount of regulation that they need to be aware of and close involvement of the FDA.

References: http://www.progenics.com/about-us/careers/posting/clinical-project-manager/

I personally believe that there is very little difference between a clinical project manager and a project manager. A clinical project manager is a type of a project manager which seems to be more focused on the clinical trial aspect of a product. Both project managers must follow schedules, protocols, and must set up quality control models in order to control the flow of the project. They are the leaders of the projects and must be able to allocate time and resources in the most practical manner. However, in addition with managing the project, a clinical project manager must monitor hospital, health, and institutional regulations set forth by the governing body for the study. They are also in charge of learning more about the participants and evaluating their eligibility for the study. They must also keep strict medical records of the each study. In comparison to a project manager, they both do the same jobs however, the clinical project manager is more geared towards clinical trials and studies.

I am a little torn on this. On one hand, I believe they are different and yet on the other I say not. Project managers are in charge of obtaining the end, desired result. This is alike for both professions but differs when considering the end result. Clinical project manager is typically only involved with medical settings. This includes ensuring those participating is following or updating the protocols and procedures as required by the institution they work for. An overall project manager is typically involved with the constraints of the community or multiple groups of people across different organizations.
Although they have similar goals in mind, I would consider a Clinical Project Manager a branch or division of a Project Manager.

The project manager is mainly involved in the early stage of a project and ensuring that the company have a clear understanding of client's goals and desires outcomes. Project manager has to perform the task related to timelines, budget , resource allocation, risk assessment. The project manager has to be plan all activity necessary for the project, organize their project team to show their full potential, control time management, monitor the progress, managing reports and necessary documentation. clinical project manager is responsible for planning, executing, organizing activities involved in clinical research. It includes interview physicians, vendors , review medical records, ascertain the eligibility of potential subjects. clinical project manager leads in planning and communication with study team to make sure study is conducted in safe and effective manner. He must ensure that proper resources are available for project and resolve conflicts and issues as well.

Project manager are the head of the project which are responsible in making sure all departments(Regulatory, Marketing, Manufacture, Quality, Clinical, etc.) complete their deliverables. Project manager creates a schedule for everyone to follow and holds meetings where all department come together and to verify and validate the document they formed for the device protocol. I think clinical project manager are the head of the clinical department where the project manager sets task for them to do. They are responsible on doing clinical research on the device. They have a team that test the device and make sure it is safe to be used. The data they collect must from the clinical project manager to the project manager and other department where they must decide if it the device validates for to be processed. So I think the difference between the two is that one clinical project manager is the head of the clinical department while the project manager is the head of project and other departments.

Project managers are found in almost all sort of organizations. The project manager is responsible for the tasks involved from the beginning phase of the project to the closure of a project which includes the planning, designing, execution and checking/controlling, cost and time estimates and management. Speaking of which the term project manager is a more generalized term. However, a clinical project manager has almost similar responsibilities which mostly are ensuring that the project is keeping up with the project aspects by making sure that all the fields related to the project are collaborating well. These fields can be the quality and regulatory assurances, medical monitoring, clinical monitoring etc.

Of course this all varies depending on the nature of the company, I believe they're both more different than you're describing. Clinical Project Managers indeed are more focused on the clinical trials and the clinical significance and relevance of the development of a project. But I believe that is their main priority and have a lot less to do with the other functions of a normal project manager. Project managers are responsible to ensure deadlines are met, priorities are established, funds are properly dispersed, and tasks are clearly identified and assigned. Many aspects of a project, depending on the project itself, may not have much to do with the clinical aspect of the project and therefore do not require the clinical project manager's input as much. However, it is the project manager's responsibility to monitor those tasks to ensure its completion.