An upcoming profession in India, Clinical research has marked its presence in past few years in a big way.
The contract research organizations (CRO) have entered our country recently only. Earlier the Pharmaceutical companies undertaking clinical research, would mostly aiding their parent company in regulatory support and medical marketing. Professionally qualified pharmacists and medical doctors would not thus consider CR as a good career option and they would rather opt for a career in pharmaceutical sales and medico marketing. Only select few of senior doctors represented investigators participating in global Multi-centric study under the direct monitoring of global sponsors. In the current scenario, we come across at least ten different types of clinical research players offering career opportunities to the future CR professionals (see Table 1).
A variety of CR business is conducted by these players, which includes bio-availability and bio-equivalence studies, Phase II-IV trials management, site management, data management, central laboratories, biotech, chemistry and biology, bio-IT solutions, and CR training. The figure 1 mentions the increasing number of CR players (presently almost 100) having a global standard infrastructure and the manpower to support the drug development initiatives.
India has always had a talent pool of scientific personnel to handle the pharmaceutical manufacturing, chemistry, discovery, biotech, and laboratory aspects of the business. However, the profession of clinical research is completely new in our country. It needs certain specific cognitive and communication skills to be attained by the professionals. The industry needs experienced and trained professionals in GCP procedures. Table 2 shows different potential career pathways for CR professionals.
The CR business in India has created several career models for graduates and postgraduates giving a plethora of opportunities to professionals from science, pharmacy, biotechnology, and medical sciences streams to look forward to promising career ahead. Table 3 enlists five distinct career pipelines that have resulted from the advancement in the vibrant CR business. each of these pipelines describe the career paths succinctly for CR career aspirants to assess their capability and pursue the one that best fits their respective potentials.
Pipeline 1 meant for medical graduates and post-graduates, this pipeline supports the clinical trial management in critical areas including safety monitoring and management, regulatory submission and approval, medical writing, therapeutic training to the clinical operations, and study team. “The scientific and medical support arm of an organization”
Pipeline 2 the “management arm of the CR business”, it is very crucial, this pipeline ensures that the trial is initiated, carried out as per the desired global and local regulatory, monitored for safety, efficacy and ethics and completed within the required time and budget. It contributes to the bottom line of CR business and makes up for 60%–70% of the CR manpower. The professionals in greatest demand in this pipeline are the CRAs and project managers, since they are the field force and revenue earners.
Pipeline 4 the support arm of the CR model, these resources bring business, identify and recruit the right professionals, manage finance and offer training to the core teams.
Pipeline 5 the investigators, are the real lifeline of the CR business, and they provide tremendous support as study staff in hospital set up for patient care, follow-up, and compliance in clinical trials.
It is essentially a people oriented business, so, a company having trained, qualified and experienced resources has an edge in terms of credibility and capability to attract sponsored projects. The recent increase in demand for trained and skilled professionals has brightened up the career prospects in this field with highered salary levels and expectations of professionals. An ever growing number of global companies are setting up their operations in countries like India because of the cheaper service costs here, the demand for these professionals is further increasing.
In the current scenario, the professionals, especially the clinical research associates, study coordinators, and project managers in India are in high demand. With an experience level of 2-5 years working with a major CRO or pharma company, the command a premium value in the job market. In order to successfully retain these employees, the global players in India offer considerable amounts of employee orientation training, on the job experience on projects, foreign travel, lucrative salary and financial incentives and perks.