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Clinical project managers plan and implement team objectives for clinical studies/trials. Clinical trials are trials conducted to evaluate the effectiveness and safety of medication or medical devices by monitoring their effects on large groups of people, according to MedTerms.com. Clinical project managers must meet a variety of skills and education requirements to succeed in this field.
Clinical project managers are responsible for organizing, communicating and evaluating team objectives for clinical studies. Their team might include clinical research associates and clinical specialists. Clinical project managers essentially plan and manage clinical trials in order to achieve quality results. They provide leadership in developing study-related documents, which might include protocols, investigator files and informed consent documents, according to MED Institute Inc. in Indiana, which identifies and develops new medical product concepts. These professionals also might have to review invoices from study vendors, institutional review board approvals, clinical study agreements and monitoring reports. Clinical project managers additionally participate in the analysis, summary and reporting of clinical data for regulatory or marketing purposes.
Clinical project managers also might supervise and assess the performance of clinical team members and train team members on daily clinical operations. In addition, these professionals must maintain good relations with investigators and sponsors, which might include physicians, medical research staff and outside consultants. They essentially serve as liaisons between study sponsors, investigative sites and the clinical research organization. Clinical project managers must ensure appropriate resources are available for a project and resolve project conflicts and issues as well.
Clinical project managers must have a good understanding of project management and must possess strong problem-solving and leadership skills. These individuals should have a working knowledge of Food and Drug Administration and other regulatory requirements as well. In addition, clinical project managers should have strong scientific knowledge and research skills. Those who have an understanding of finance and the grant application process also have an advantage when working in academia and nonprofit organizations, according to DegreeDirectory.org.
Clinical project managers usually must have a bachelor’s degree or above in an applied science field. For example, a major in an area such as biology, chemistry, microbiology, health, life sciences or biomedical engineering is suitable for clinical project managers who work for pharmaceutical, health care services or medical device companies. Some employers actually hire only individuals with a minimum of a master’s degree in a related field. Many employers also look for job candidates who have multiple years of clinical trial operation experience. Some additionally look for individuals who have experience in writing study protocols and other technical documents.
The demand for clinical project managers remains strong with interest in pharmaceutical research escalating along with growing demand for quality health care in the United States, according to DegreeDirectory.org. The outlook is especially strong for experienced clinical project managers who have graduate degrees.
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