Project Management

Project management is a combination of techniques, procedures, people, and systems focused on the successful completion of a project. It is also a discipline that will support the planning, implementation, tracking, and control of projects.

Why do I need Project Management?

To enable delivery of high-quality results that are within scope, time, and cost constraints with unparalleled customer service. To ensure all individual pieces come together in line with the client's strategy.

What are the benefits of project management?

Project management ensures that the project does not veer off its intended pathway. This begins in planning, all the way through initiation to completion.

Project management responsibilities include:

  • Clear communication: managing project meetings; providing frequent status reports; serving as central point-of-contact for clients, internal teams, site staff, and vendors
  • Attentive management: responding rapidly and comprehensively to client requests; determining and disseminating client expectations to the project team; maintaining client-specific guidelines
  • Thorough planning: preparing comprehensive project plans with detailed timelines; anticipating and addressing issues that may otherwise hinder achievement of time-sensitive deliverables; applying data-based decision-making skills
  • Skillful implementation: overseeing optimum performance of all teams, services, and technologies affecting project outcomes
  • Dependable control: monitoring contract and scope fulfillment and compliance with stipulated regulations and standard operating procedures
  • Efficient closure: Accurate analysis and reporting, maintaining and archiving all project documentation and holding lessons-learned meeting with project stakeholders
  • Budget management: Be responsible for robust planning and ensuring that as much as possible, the team stays within the budget. Phase budget expenditure, e.g. into quarters, to have a useful tool for review. Demonstrate how changes to the plan will impact budget, which may allow reallocation of budget if a project is delayed or if need be. Review the budget regularly to ensure its accuracy and stop those nasty surprises.

Who should be the Project Manager?
The project manager in most cases serves as the liaison or the contact person during the project, between the stakeholders/ funders and the team members. This therefore requires excellent communication skills and public relations. Its part of the project manager's job to try and find the best fit between a task and a resource. The better the match, the more likely the estimate will turn out to be accurate. In an ideal world resources are available whenever you want them. In reality, resources are often coming from a shared pool. This is one of the first things that can impact a schedule right. Once work has begun, it is important to review the resource issue regularly, keeping in mind that you expect what you inspect. There are many tools that can be used to level resources. Whatever tools chosen, aim for perfection and focus on getting the project done.

Other things to consider when building and managing a team include:

Trust: Be Open and Honest
Be as open and honest with your team mates as you can. Answer their questions directly and act as a conduit of information for them, not a barrier. If you feel you cannot divulge something, say so. Your team will appreciate your honestly and reciprocate by relaying information and producing honest and accurate estimates for you.

Equality: Be Fair and Even Handed
One of the maxims to live with as a manager is, "individuals can succeed but only the team can fail". Essentially this means that in public you should dish out credit wherever it is due but never criticism. Being criticized in public, in front of your peers, is not a motivating force for anyone.
If there is a project issue that needs to be addressed you can normally broach it as a subject for the whole team to address. By sharing the burden for issues, most teams pull together to solve the problem. By landing it on the shoulders of one or more individuals you often split the team and cause conflict. Open discussion of the problem will encourage the team to take ownership for the problem and solve it themselves.

Loyalty: Protect Your Team
You will have a split responsibility – on the one hand you have a duty to your client to see the project succeeds – on the other you have a responsibility to represent your team and to support each other. Usually these two aims should be neatly aligned but not always!
In a situation where you have to choose between the two you need to take the difficult moral stance, don’t air your dirty laundry with the client. Discuss the situation with your team mates and come up with a solution, present this to the client instead.

Learn to Delegate
Proper delegation entails laying out the task to someone that understands it, so that it has reasonable and achievable goals and so that you give them all the support they require getting the job done.
It also entails giving them enough room to get the task done on their own. If you leave the execution of tasks to them they will, in return, leave you alone to get on with your job. If you spend you time looking over their shoulders it will only annoy them and waste your valuable time.

Tracking
During the life of a project, it is the project manager's responsibility to track and control the progress.
In the area of tracking, the project manager should make sure that the process isn't too involved so as to slow down progress. At the same time, it should be effective enough to identify issues early. It's also important to track only things that are actually important to the success of the project. A lot of people fall in to the trap of tracking nice-to-know things rather than need-to-know things. One commonly used tracking item is the idea of a milestone. A milestone marks the completion of some set of tasks that are significant in some way.

Control
Change is inevitable with projects. If a change request is going to add costs to the project, it should be noted. If a change is going to force the schedule to expand, it should be noted. These items should then be reported to the project stakeholders with the goal of getting approval to proceed with the change request despite the impacts. In this way, the project manager controls the change without derailing the project.

Status reports keep people in the loop so that they don't need to make assumptions about progress. The reports also keep the project up front and center in the minds of those that are impacted by it.
Projects of significant size are rarely problem free. The project closure step is the time to reflect on the bumps along the way so that they can be avoided in future projects. The trick here is remembering what went wrong and correctly identifying why it went wrong without letting the exercise degenerate in to a finger-pointing session.

Project Team

When running a project, it is imperative to have a team that will steer the project. When forming the steering committee or team, there are a few things to consider:

  • Steering team is a representative of all the functions that are needed for the project to succeed. This should include the key people like heads of the project departments e.g. lab manager, data manager etc.
  • Initially it may be a good idea to have just a core of a few key people who are really responsible for driving the project. As the project advances, then include others as needed. Also others can be invited at specific / relevant times. The advantage of having a small group of key people is that it will be easier to get these together on a regular basis (see team meetings below) and it is easier to make conclusive decisions.

Project Team meetings

Project Team meetings are key to the successful running of a project. As a Project Leader / Project Manager this is your main tool for keeping in touch with all aspects of the project. It is also a vehicle for keeping everyone focused, feeling part of the team and informed. As mentioned above these will involve your core project team and potentially selected others at specific times. How often you meet may vary depending on the stage of the project and what the team believe is needed. Some basic rules:

  • Meetings need to be few but regular. This will keep the team focused and involved.
  • Try to keep meetings as short as possible. One to two hours should be a maximum for a regular meeting. If not people will lose interest. If they go on for much longer it probably means that you are trying to involve everyone in every decision.
  • If issues arise that cannot be dealt with quickly appoint a select small sub team to deal with it and either report back next meeting or circulate the outcome if more urgent.
  • As team leader / project manager it is your job to coordinate the meetings.
  • Have a clear timed agenda for each meeting.
  • Give each team member / project function a short slot for reporting activity (even if they say nothing to report on occasions). This will focus them on updating succinctly for the benefit of you and other team members.
  • If you have key issues to discuss give these separate agenda items (don't try to cover everything in the reporting section) and put them early on the agenda. Then even if you do run out of time you have covered the most important items
  • Things like budget and project plan reviews should be standard items (again even if there is little to report).
  • Take short but accurate minutes and circulate these quickly after the meeting. As part of the minutes all agreed actions should be noted with a person responsible and timing. I would recommend that all actions are recorded on a separate table, which can then include any ongoing actions from previous meetings. This will make it easier for all to follow.
  • At each meeting review the progress of all actions: Note any that are completed; Include progress updates for those not completed / ongoing; Note for yourself any that may need your involvement to push them along.

Project Plan

You would not start off on any long journey without knowing why you are going, some knowledge of the route, the distance and how long it was going to take. The same is true of a complex project , it will have a defined objective, planned start and end dates and a plan to get you there.
So how do you put together a comprehensive and robust project plan?
Have clearly defined and agreed objectives

  • Clearly defined so you will know what the end point will be.
  • Agreed with your sponsors and with the team who will be running it.

Get that project team you have selected together before the start of the project and brainstorm the plan.

  • At this point you could even explore and understand some of the major risks to the plan.

Have some means of visualising the plan so that everyone can understand. These days the GANNT chart seems to be the most universally used. Although using dedicated software (e.g. Microsoft Project) to produce these is not essential it is by far the easiest and most flexible option.

  • A picture of the plan will also give you other useful information e.g. the critical path, those activities that drive the timeline.
  • It is also the easiest way to look at scenarios, to play "what if". If things go wrong, as they will, and timings change you can instantly see the overall impact on the project. Also what effect moving / shortening other activities might have to help compensate for time lost etc.

Review the plan on a regular basis at the team meetings and as stated above plot any changes / potential changes.

Project Management Process

As stated earlier, visualizing the plan will enable the team have a clear understanding of the project and the pathway to be followed to the end point. Below is a figure representation of a project and following the figure is an explanation of the specifics during each phase.

PLANNING

Each clinical trial project is unique and complex. Considering these complexities, management of many resources is extremely imperative and requires a solid yet flexible plan. The flexibility ought to be able to accommodate changes likely to occur during the project running. The plan should be formulated through tactical discussions with all stakeholders. These discussions will help generate timelines, plan resources and determine best practices in line with GCP, to complete work efficiently.

INITIATION

The study initiation visit is a meeting conducted by the sponsor study monitor to inform the
investigator(s) and study staff about the details of study procedures. This meeting occurs after the pre-study visit and selection of the investigator (both visits may be combined), after all study arrangements have been made and the investigator(s) is (are) ready to enroll subjects. During the
visit, the sponsor staff will usually go through the study protocol, procedures and CRFs with the investigational site staff in great detail to ensure that all persons involved understand exactly what is required. Following this visit, the site can then begin to recruit subjects into the study.

MANAGING

Projects need to be managed right from the planning phase. As they advance, managers with their team need to ensure that the projects don’t veer off their intended pathway to completion. This includes adequate supplies, sufficient tools, and efficient human resources. While being executed, the plan needs to be measured and monitored. Regular communication of the progress in terms of scope, cost and quality should be implemented.

IMPLEMENTATION

During project implementation, meetings need to be held regularly to enhance team performance and review study performance. It is in this forum that need for team training is raised and quality assurance issues addressed. Continual and regular communication between project manager and all stakeholders in this phase, will lay a platform that will facilitate decision making, should there be changes as the project advances.

CLOSURE

At this point, the project work should be completed. Ensure that all needs have been met, documentation produced through out the project has been compiled and archived. Any products that were not used need to be disposed off properly according to protocol and within guidelines and regulations. Reports are written and analyzed at this point. All stakeholders reflect on lessons learnt through the course of the project, and best practices carried forward.

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