PROJECT MANAGER IN A REMOTE CLINICAL TRIAL SETTING

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Now that you have been appointed the Project Manager of this big or small project, three things should be clear to you: 1) What objectives you are to achieve 2) Within which period of time 3) With what resources In other words, a detailed description of the project you are to manage should be given to you, with a specific date of starting and termination and with a clear description of the resources available (human and material) in order for you to complete your task effectively. No matter the size of the project given to you, the issues concerning the what, when and how should always be addressed and documented appropriately, as they will guide you through your project and enable you to attain your objectives. I. Definition of straight forward, reasonable and attainable objective. A/ why is it important to define objectives? As experience would show, it is very easy to get carried away in a remote clinical research setting, especially when a trial is about to start, the staff is not fully on board and responsibilities aren’t clearly defined. Before the commencement of the project, or if you just realized that: - the project coordinator has set his objectives and awaits you for results, - the staff is freshly recruited and probably not experienced and look up to you for directions,and - the daily tasks mentioned in your job description are piling on the table each demanding for your urgent attention, then you need to STOP everything and redefine your straightforward, reasonable and attainable priorities. Independent of the size of your project (either a small drug trial in a single setting or a multidimensional trial involving several sites in different countries), it is always important to agree on a clearly defined work plan early enough, which should specify: - The goals of the project - The specific responsibilities of the manager to achieve these goals - The milestones and deadlines for the completion of every task - The resources in term of personnel, equipments and finances available for the manager to complete the project Once the work plan proposed by the Project Coordinator/Funder is understood and agreed upon by the Project Manager, then the work can begin. B/ Straight forward, reasonable and attainable objectives It is primordial to set straight forward, reasonable and attainable objectives in order to avoid bad surprises, misunderstandings and eventual failure of the project. This can be achieved by: - Brain storming and discussing aim and objectives within the team before reaching to a final decision - Using available data or experiences from people who conducted a similar project - Specifying individual and team goals and responsibilities, in line with the common objective Moreover, it is important to know that every work plan needs to be operational as the situation on the field often differs from the best written protocol. Therefore, even if everything has been carefully planned and documented, there should always be room for amendments to readjust the previously set objectives. II. The importance of time Time is a key factor in the realization of every successful project. There should be for every task within the project a specific start date, a time limit for accomplishment and a date of closure. The Project Manager is responsible to set and organize his/her priorities in order to meet up with the deadline of the project as far as milestones, deliverables, budget expenditures or expected end points are concerned. For every delay in a major milestone, provision should have been made ahead of time for necessary amendments, and explanation/justifications should be made available for the different stakeholders (funders, investigators, coordinators, monitors, and if necessary study participants) on the reason of the delay, the corrective measures taken, and actions considered to avoid further occurrences. III. Human and finance resources The management of the project team and the budget will have a serious impact on the success or failure of your project. Your skill as Project Manager will show in your ability to bring out the best of every resource given unto him, whether ideal or not. A/ the project team An ideal project team would be a bunch of high techs professionals, carefully selected by you for their good experience and strong motivation, and their capacity to meet management demands, within time and without constraint. Unfortunately, it is often not the case, as you can be hired to manage a project within an existing team of non experienced newly recruited young professionals, lacking motivation and looking up to you for the completion of every single tasks. Your challenge here will then be to create within this disparate group a team spirit, and to steer within each individual a sense of ownership and a desire to succeed for the benefit of the project. To achieve this, providing appropriate information and establishing good communication within the team are good ingredients for a start. Once the team is well informed on the objective to attain, the next necessary step is to equip them adequately to attain this objective. Emphasis should be put on trainings and feedback meetings to evaluate the progress of each team member and their capability to perform the task assigned to them. This whole process will guide the appropriate delegation of responsibilities. NB: You should however always remember that delegating a well understood task does not prevent you from cross checking from time to time the progress of your collaborators as the outcome of every decision (good or bad) lies on your own shoulders. B/ the budget The preparation, implementation, analysis and reporting of the budget are the responsibilities of the Project Manager. A good comprehension of the project, and consultation with key members involved would enable you to plan adequately and avoid shortages or excesses. However, room should always be made for unplanned events as they might cause delays in the advancement of the project and therefore an increase in expenditures. A good budget should make provision outside of the fixed expenses, for inflation, exchange rate, back up equipment and overhead expenses. It is advisable during the course of your project to create an excel file to follow up on a weekly basis the real expenses in comparison with the forecast. This will enable you to know at each point in time if your rate of expenditure is on track or exceeding your expectations, which should flag you for necessary adjustments. NB: You must always separate in your mind the budget allocated for the project and the cash actually available. This will help you on your daily management. TAKE HOME MESSAGE: You have been given this project to manage and you can do this. To get things right from the start, it is important for you to get the full support and confidence from your Project Coordinator/ Funder, as this will help you a great deal to get the full support and cooperation from your team. Remember that you are all there to learn, adapt and gain experience from this project for the next to come.