Who is a Clinical Project Manager?
A clinical project manager is one who plans and implements team objectives for clinical studies. Clinical trials are conducted for evaluation of the efficacy and safety of investigational drugs or medical devices by critically monitoring their effects on larger population. As a clinical project manager, you would require several skills and educational requirements to succeed in this field.
A clinical project manager will be the main point of contact in any clinical trial. He/she works closely with other clinicians in order to ensure that the clinical trial has been appropriately designed and implemented properly. He/she is also responsible for ensuring that the resulting data is collected, stored and analyzed properly. In addition, a clinical project manager will also be responsible for ensuring that the trial is successfully completed on time and within the budget parameters. This role also needs continuous attention to flow process and a sharp eye towards identification and improvement of existing procedures and processes. Since the job involves liaison with different roles in a high profile manner, the individual must have excellent communication skills. (1), (2)
The clinical project managers have the responsibility of:
- Communicating, organizing, and evaluating team objectives for agreements and monitoring reports
- Being a part in analyzing, summarizing and reporting of clinical data for marketing or regulatory purposes
- Assessing and supervising the performance of clinical team members and training them on everyday clinical operations
- Maintaining good relations with sponsors and investigators including:
o Medical research staff
o Outside consultants
- Communicating with:
o Clinical research organization
o Study sponsors
o Investigation sites
- Making sure that appropriate resources are made available for a project
- Resolving any project issues and conflicts (1)
How to become a Clinical Project Manager?
Most typically, the clinical project managers must have a bachelor's degree or above in an applied science field. For example, a major in any of the following subject is ideal for clinical project managers who work for pharmaceutical, health care services or medical device companies:
- Health or life sciences
- Biomedical engineering
Some employers hire only individuals who hold a minimum of a master's degree in any related field. Many employers also hire candidates who have more years of experience in clinical trial operations. Additionally, some look for individuals who are experienced in writing study protocols and other technical documents. A four-year degree is often required in addition to clinical and nursing experience.
The clinical project managers need to have a good understanding of project management and need to possess strong leadership and problem-solving skills. They need to have a working knowledge of Food and Drug Administration and other regulatory requirements as well. In addition, they should possess strong scientific knowledge along with research skills. Those who possess knowledge of finance and grant application processes will be at advantage while working in academic and nonprofit organizations. (1)
In the United States:
The clinical project manager certification is evaluating the ability of the applicant to apply and adapt principles and concepts for successfully achieving the desired objectives and goals of the project. Certified Clinical Project Manager (CCPM) certification provides a detailed assessment regarding the application of:
- Administration of the best practices for clinical research
Thus, this program is ensuring clinical trials to be efficient and safe. The CCPM certification examination is regularly conducted. Upon passing this examination, the candidate will be awarded the designation of "Certified Clinical Project Manager" with a seal that is valid for 2 years.
Clinical research professionals who are directly or indirectly involved in clinical trial processes should obtain this certification. Whether you work as a clinical research associate, project manager, clinical study manager, project coordinator, clinical logistic manager or project lead, this certification would provide an assessment and certify your expertise and experience you have acquired during your clinical research career.
Clinical project managers with project management experience could obtain higher skills to enhance their knowledge and understanding of how CRO companies and sponsors should ethically and efficiently conduct clinical trials. This certification will lead to higher positions in clinical research and related industries.
Eligibility for Certification:
Applicants who aspire to become eligible for this certification program need to display a combination of educational background and evidence of work experience in clinical research. (3)
The outlook is strong for experienced clinical project managers who have graduate degrees. Employment opportunities for clinical project managers typically exist in:
- Physicians' offices
- Contract research organizations
- Specialty disease centers
- Biomedical research organization
- Pharmaceutical companies
- Medical device suppliers
Positions in this line of work are expected to increase by 20% or more in the next 10 years. (4)
In the United States:
Clinical project managers are getting an average pay of $30 to $48 per hour with an average annual salary of $63,000 to $100,000 based on educational degrees obtained, the research setting, credentials and experience. Median pay for Clinical Project Managers in the United States is around $84K annually.
The clinical project managers' overall cash allowance can sometimes be more than $15K from bonuses and in some exceptional cases, $22K from profit sharing thereby causing incomes to vary widely between $54K and $128K. This group's pay is mainly influenced by geographic location, followed by years of experience and the particular employer. Medical benefits are provided to almost all members, and most of them are having dental coverage.
In India, a clinical project manager is earning an average salary of Rs 797,477 per year. In the country, most clinical project managers are found to move on to other job positions after completing a decade in this position. A clinical project manager having project management skills is associated with a higher pay for this job. (5), (6)