Pros and Cons of a Career as a Clinical Project Manager
As a clinical project manager, you may oversee and assist with a variety of clinical research trials for prescription drugs, medical equipment or other consumer products. Continue reading to learn about the pros and cons of this career to decide if it's right for you.
| Pros of Being a Clinical Project Manager |
|---|
| High income potential ($136,000 mean salary for natural science managers)* |
| Ability to combine administrative skills with scientific research* |
| Work in comfortable environment* |
| Opportunity to participate in new product development* |
| Cons of Being a Clinical Project Manager |
|---|
| High education requirements* |
| Slow growth and high competition for jobs (6% growth projected from 2012-2022)* |
| Many years of experience required for most positions* |
| Extensive knowledge of government regulations required** |
Sources: *U.S. Bureau of Labor Statistics, **U.S. Food and Drug Administration.
Career Information
Job Description and Duties
Scientists and technicians conduct research trials for a variety of products, including a growing number of prescription drugs. Clinical project managers are often tasked with hiring these professionals, supervising their work and communicating their findings to top executives. You may be tasked with maintaining records, enrolling study subjects, performing quality assurance audits and providing technical assistance in the laboratory.
As a manager, you will most likely need to follow regulatory guidelines set out by the U.S. Food and Drug Administration (FDA) for Good Clinical Practice (GCP), Good Laboratory Practice (GLP) or even Good Manufacturing Practice (GMP). These regulations cover areas of clinical research such as the protection of human subjects, informed consent of subjects, adverse effect disclosure, toxicity, risks, new drug application procedures and financial disclosure of clinical trials. In adhering with FDA regulations, you may be in charge of designing, implementing and adjusting study protocol. You will maintain budgets and perform human resource tasks, reporting all types of study findings to top executives or directors.
Career Outlook and Salary Information
Many careers in prescription drug and medical device development are growing rapidly, according to the most recent data available. However, the U.S. Bureau of Labor Statistics (BLS) noted in 2012 that the consolidation of management positions and the outsourcing of research to specialized firms are contributing to slow growth for natural science managers and clinical research coordinators. The BLS projects 6% growth in employment from 2012-2022, slower than the national average for all occupations. The BLS also predicts a high level of competition for these jobs.
The majority of these professionals are employed either by government regulatory agencies, such as the FDA, or in developmental research for drug manufacturers or specialized research firms. The BLS reports a 2014 mean salary of $136,000 for natural science managers.
Requirements
Clinical project managers generally come from a background of natural science and business management. Strong computer skills are essential for database administration, study analysis and creating spreadsheets for budgets and study results. You will also need strong oral and written communication skills to report findings and other information to both technical and non-technical researchers and executives.
Education Requirements
The Occupational Information Network (O*NET) reports that 56% of clinical research coordinators earned a bachelor's degree, while 12% of these professionals earned a master's degree. Many clinical project managers pursue the highest degree in their chosen field of study, such as engineering, biology, chemistry or other relative field. Advancement into management positions may require years of experience in laboratory research as well as a business or administrative background.
Real Job Listings
Knowledge of GCP, GLP and GMP regulations are extremely important for most clinical project management positions. Depending upon the area and level of research being conducted, varying education levels are required. Here are a few real job listings in clinical research management from April 2012:
- A Denver research firm seeks a clinical trials project manager/specialist to coordinate clinical studies for a variety of homecare therapeutic services. Successful applicants will be in charge of budget and deadline provisions, tracking progress of trials as well as being a liaison for vendors, pharmacies and homecare agencies. A bachelor's degree in science and excellent computer skills is required.
- A pharmaceutical manufacturer in New Jersey seeks a clinical research manager to design, coordinate, monitor and report pre-clinical and clinical field studies for pet care products. A master's degree and five years of experience or a doctoral degree in veterinary science is required.
- A clinical research firm in Maryland seeks a quality control manager to develop and direct testing for vaccine products. Duties include laboratory monitoring, creating summary reports and assisting the clinical research manager. A BA or BS degree in engineering or science is required, plus GLP and GMP regulatory knowledge and experience.
- A Maryland firm seeks a clinical project manager in charge of proposals, contracts and funding for research projects. While a bachelor's degree is required, a master's or Ph.D. is preferred. Five years of experience in biopharmaceutical project management is also necessary.
How to Stand Out in Your Field
Pursue Specialized Degrees
Job applicants for many positions in clinical project management are required to possess a minimum of a bachelor's degree. However, gaining research experience may entail completing an advanced degree and/or certificate in your chosen area of scientific study. In order to stand out, professionals may also choose to pursue a Master of Business Administration (MBA) or a specialized graduate degree or certificate, such as a Master of Science (MS) in Clinical Research Management, an MS in Clinical Laboratory Management or a Master of Management in Clinical Informatics. Certificate programs offered to graduates and professionals include Pharmaceuticals and Clinical Research Management or Clinical Research Conduct and Management.
These programs can provide you with the specific practice and regulatory background you need to be competitive in your career. Course topics such as data management, clinical protocol, subject recruitment and vendor selection can prepare you for laboratory administration. Other business topics in your advanced degree or certificate program may include marketing, statistics, planning, budgeting, quality management and computer applications.
Gain Professional Certifications
As you enter the field of clinical research management, you may wish to gain professional certification from organizations such as the Project Management Initiative (PMI), the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA). Issued by SoCRA, you may obtain the Certified Research Professional credential. You may also choose to obtain ACRP's Certified Research Associate (CRA) credential or the Physician Investigator (PI) credential for licensed physicians involved with clinical research. As a management professional, you may also choose to obtain PMI's Project Management Professional (PMP) certification, with eligibility requirements that include a bachelor's degree plus 4,500 recorded hours of project leadership.
Alternative Careers in Research and Development
Medical Research Scientist
Like many clinical project managers, medical scientists participate in clinical trials and pharmaceutical testing. You may also be in charge of preparing proposals and providing assistance to the project manager, including the supervision and leadership of research technicians.
According to the BLS' 2010-2020 projections, employment for medical scientists is expected to increase by 36%, due in large part to the continued growth in pharmaceutical drug development. Based on 2011 data, the BLS reports that these professionals earned a mean salary of about $88,000.
Biomedical Engineer
Biomedical engineers participate in the growing field of developing medical instruments, equipment and diagnostic technology. The aging population in the U.S. should continue to spur a growing demand for medical equipment such as knee and hip replacement materials. Although still a relatively small occupation, the BLS projects that jobs in this field will increase 62% from 2010-2020.
As a biomedical engineer, you will need a strong background in biology, mathematics, engineering and computer technology. Based on O*NET data, 45% of these professionals earned a bachelor's degree, 35% earned a master's degree and 20% earned a doctoral degree. Based on BLS 2011 data, biomedical engineers earned a mean salary of about $88,000.
