Clinical project managers are key facilitators in a clinical trial's progression. This professional manages all aspects of these experimental trials, including the trial's staff, schedules, budgets, and stakeholders. Understanding clinical project manager roles can help you determine if this career path is suitable for you. Clinical Project Managers manage the entire research lifecycle by putting together a plan and executing it and using their strategic thinking, leadership ability, and understanding of the regulatory environment.
The therapeutic arena is getting hotter with every passing day in the race for novel therapies; hence, a need for managerial expertise is at an all time high, with organizations recognizing them as playing a critical role in the success of a trial.In this article, we discuss what a clinical project manager is, walk through steps to becoming one, highlight skills that the role often requires.
What is a clinical project manager?
The Clinical Project Manager is an expert in clinical research and healthcare management, bringing great experience to bear on planning, execution, and monitoring of clinical trials, with an aim toward regulatory compliance, timelines, and budget.
This multifaceted role connects research teams and sponsors with government authorities and other parties in order to facilitate communication and collaboration.
The Clinical Project Management protocol development, risk management, team leadership, and the intricacies of regulatory compliance. While working successfully to do this, he/she applies extensive knowledge in project management, scientific retrieval, and regulations to enrich the process of making great clinical trials that continue to new knowledge in medicine and the delivery of new treatments to patients who need them.
What does a clinical project manager do?
In my experience, an essential component of any clinical trial, rather, any drug, therapeutic, or medical intervention study is the clinical project manager. CPM is basically a person who is in charge of many other processes carrying from a successful running of health research to many applying factors. He integrates many fields of science and some areas of project management, in order to see to the smoothness of clinical trials.
Some of the other roles and responsibilities that are key for a clinical project manager are:
Planning: Draw up the strategic and technical plan for the initiation, execution, and completion of the clinical trial; this should be in line with project goals and timelinesProtocol development: Have an input into the writing of a study protocol, which describes all aspects of methodology, objectives, and parameters for identifying the study populationSite selection: Identify and select suitable clinical trial sites based on local trial site patient demographics, local facilities, and regulatory constraintsRegulatory affairs: Navigate through and ensure adherence to all regulatory framework by obtaining all necessary approvals and permissions in the clinical trialBudget management: Manage all budgeting aspects of the clinical trial; ensure compliance to the allocated budget on expenditures and wisely decide on the actions of resource utilizationData integrity: Undertake supervision of the collection of data and its management, focusing on data accuracy, completeness, and compliance with regulatory standardsTroubleshooting: Identify all issues or obstacles that may be faced during the trial and then make decisions in consideration of patient safety and the study's credibilityQuality assurance: Focus on the quality of the whole clinical trial process and use any effort possible to ensure ethical standards, safety of patients involved, and credibility of results drawn from research.Skills Required for a Clinical Project Manager
The following are some skills that clinical project managers regularly exhibit:
Leadership: Leadership skills allow clinical project managers to guide their teams through the establishment of industry-standard procedures. Such approaches enhance the ability to make diverse groups of staff members as well as trial subjects collaborate with each other. Communication: Clinical project managers often use their communication skills to relay important instructions to the team. They also use them to develop rapport with research staff, sponsors, and investigators. Writing: Writing skills are essential in creating such documents as contracts, written protocols, grants, and consent forms, and clinical project managers use this skill to check documents for spelling and grammatical errors. Financial management: Clinical project managers rely on financial management skills to ensure that a clinical trial is conducted within budgetary constraints. It also assists them to pay invoices and conduct daily accounting assignments. Analytical: Analytical skills allow a project manager to traverse the problem identification aspects of clinical studies and pinpoint solutions. They apply their analytic skills to predict and interpret project results and design plans to fulfill organizational aims. Research: Clinical project managers often use their research skills to keep up to date with information concerning emerging healthcare technology and data analytics. These professionals can also use their research skills to find solutions to very challenging clinical problems. Collaboration: Clinical project managers apply their collaboration skills in establishing realistic team expectations and delegating duties. This further aids the employees in reaching their own goals and allows for support if needed. Time management: Since clinical project managers often supervise multiple studies, they might use their time management skills to keep their organization. This tool allows them to plan and prioritise tasks to ensure that trial completion is not delayed.How to become a clinical project manager
A short list of six areas or steps that one can take in order to begin a career as a clinical project manager:
1. Earn a bachelor's degree
The British Academy For Training And Development emphasizes the importance of volunteering and social participation in health institutions management.Most clinical project managers have bachelor's degrees in biology, health and life sciences, nursing, or bioengineering. An undergraduate program in one of these areas may expose you to subjects such as genetics, psychology, human anatomy, chemistry, and mathematics. These subjects may help support a clinical project manager's understanding of some of the basics of clinical research and the scientific principle.
2. Pursue a master's degree
After an undergraduate degree, some clinical project managers pursue a master's degree in business administration, science, or public administration. These programs typically span two years. Having advanced degrees enables professionals to find work faster as clinical project managers than undergraduates. Researching qualifications and requirements for clinical project management positions within your locale should give you guidance on whether you want to follow the pursuit of education.
3. Entry level clinical job
Potential clinical project managers often start after graduation but find a job in the medical or pharmaceutical industry. Some entry level positions include clinical team lead, clinical research associate, clinical team manager, and clinical operation lead. All of these jobs provide clinical leadership and management training.
4. Get experience
Continue working at entry level to familiarize yourself with clinical practices and regulatory requirements. In this way, you may learn to write scientific documents such as trial protocols and get experience communicating with institutional review boards and ethics committees. These skills will all be very important in allowing you to gain higher level positions in clinical project management. After working an introductory job in a clinical setting for seven to nine years, you should qualify for a position as a project manager for clinical studies.
5. Prepare your resume
Having gained some experience, you should now create your resume and submit applications for jobs in clinical project management. Choose a resume style that focuses on your work experience and project management skills. You can also consider adding an education/other training section. As you build your resume, refer to the job description so that you can highlight the attributes the position requires.
6. Secure a job as a clinical project manager
After satisfying the educational and experiential requirements, now it is time to consider the available clinical project managers' opportunities. Job advertising is available through websites or may be found through your professional network. Use the resume that you created in the previous step, customizing it according to the job at hand for each application.