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Project Management needs to evolve hand in hand with the technological advancement as the survival and sustenance of a Project Manager will depend on
a) Embracing technological advancement
b) Consistent technological up-skilling
which will enable a Project Manager to achieve technological fitness for executing Projects with high standards of key performance indicators. Technological advancement has been a major contributor to the clinical trial industry. Though initially there was some resistance in accepting the change quickly however the industry has realized this quickly as to how important is to accept the reality of technological innovation and reap rich dividends.
Project Manager needs to keep pace with the technological innovation as Miniaturization and technological obsolescence happens so fast. Hence Future Project Managers will have to be well versed and adaptable in terms of patronization and utilization of new gadgets into Clinical trial arena which will enhance the speed, accuracy of the Clinical trial data analysis.
Technological innovation will be of 2 types namely disruptive and constructive. Project Managers needs to adapt both types of innovations quickly. Disruptive innovation requires a sea change in terms of processes, mind set etc. and will pose challenges in terms of acceptance however in reality the industry may not have a choice other than to accept and welcome the innovation due to the significance in terms of cost, time and other benefits.
Clinical project typically consists of various phases such as initiation, Planning, Set up, Maintenance and close out. In all the above phases, contribution of the project Manager who is the epicenter of the project plays a key role in the successful execution of the Project. Communication is one of key aspects of Project Management and an important quality a project Manager must possess as he has to consistently communicate and co-ordinate with the Sponsor, other functional stake holders and also with his / her team to ensure that the deliverables are met with high standards. In addition to the Communication skills, a Project Manager should have good negotiation skills and interpersonal skills as well. Project Manager is the face of the organization to the Client and has to consistently delight the customer to achieve the end goal of repeat business. Project Manager will have to provide the right project oversight by ensuring :
a) project execution within the budget
b) exercising consistent cost control,
c) optimal utilization of the resources
d) increasing efficiency
e) maximizing Quality.
Since the patient recruitment and the consequent electronic data collection may not happen as planned, a DM PM will always have to be proactive and address resourcing challenges in time to ensure on time delivery.
The project management role is really critical in running the clinical trials and to communicate the priorities across stake holders. An intense knowledge is always a key to plan out everything and run the trials efficiently. The project management team co-ordinates on feasibility, patient recruitment, risk mitigation, categorizing the operational challenges, Study design, Data Review, timelines, quality and much more for ensuring the good health of the study. Also they have to liaise with different stake holders to put all those things together and ensure quality delivery. The holistic conduct of trial depends on the knowledge which they possess on the process and technology.
On the other side we have a serious innovative disruption changing the way we conduct the clinical trials. It has also become a key differentiator for project management team to be aware of the technology break through and their impact on clinical trials. The drug compliance through digital systems, patient assessment through EHR, wearable devices, Real world evidence, block chain, automation in reducing the redundant tasks or multiple reviews is evolving as a critical need in the future. It is also need for the era to understand how this will positively impact the project management capabilities in the future. Please share your thoughts on technologies that will influence the future of clinical trial project management and challenges. Also share your views whether new technologies will help project team to solve the mysteries in patient recruitment and engagement which is still a paradox in clinical data management.