Globalisation is demanding. It is volatile in nature. It is stressful - whether you succeed or fail. Also, it is here to stay - whether one approves it or not. One sector of industry in India that has immensely benefited from globalisation is clinical research, which deals mainly with drug discovery and development.
During 1996 to 2000, USA outsourced 4230 clinical trials and India could bag only one deal. However, during 2001 to 2005 USA outsourced 12022 trials and India bagged as many as 192 orders. As of 2006, in India there are about 1000-1200 sites that conduct clinical trials. Out of these, 207 sites are registered with Food and Drug Administration (FDA). It shows how the business and its outsourcing are growing. Also, it shows the leap India has taken and what it is poised for the future. According to Industry Research Solutions' estimates Indian clinical trials market is expected to grow at a compound annual growth rate (CAGR) of nearly 36 per cent between 2006 and 2011 to register revenues worth US $546 million. In 2004, BioSpectrum listed about 20 leading clinical research organisations (CROs) that do at least some of their trials in India. There are over 100 CROs in the country today (supplementary material). The drug control general of India (DCGI) is receiving more than 20 applications a month for conducting trials, including those for which permission to test has already been received in highly regulated markets such as the USA.
It is interesting to find out "Why is India being favoured as a destination for clinical trials?" One of the biggest advantages of conducting clinical trials in India is the availability of a large patient pool that can be recruited at much shorter time than it takes to recruit patients in the west. India by 2011 will be conducting more than 15 per cent of the total global clinical trials. Another asset is that India claims second largest pool of qualified doctors needed as clinical investigators. Even with cost competitors (like China, Russia, Turkey, Brazil, Mexico) India has the advantage of English as a primary language of education and communication. Sensing the potential India has made legislative reforms, regulatory initiative and instilled administrative efficacy to offer right environment conducive for outsourcing.
With outsourcing on a progressively larger scale across the world, most CROs find it difficult to hire staff with experience. This inevitably results in skilled manpower shortage that limits growth of the clinical research industry. Also, it is sure to affect the quality of work output. With the demand exceeding supply there is incidental job hopping by those handfuls, who are experienced. With high attrition rates the salary expectations increase; promotion criteria are diluted; advantage of induction training is lost; organisation memory gets lowered and chasing the timelines becomes difficult. Such a situation is a nightmare for any organisation. On one hand, the CRO must keep to the timeline commitment given to the sponsor. On the other hand, makeshift arrangements are costly - reducing the profit margins drastically. It does not make business sense.
Addressing the issue of "inadequate" manpower ought to embrace a number of scenarios over and above "manpower shortage." A start up CRO needs to get a critical mass of employees with senior staff joining first. This causes gross manpower shortage across the board. Even when initial appointments are made, it takes time to establish hierarchies and channels of formal communications. There is neither work ethics nor ethos to refer back to. Such an organisation may have optimum number of employees. Yet they are "inadequate" for the need.
Another scenario that keeps on recurring in any organisation is the "varietal manpower imbalance," where the person crucial for the job are not on board or resign and the ancillary staff has no assignments to perform. This becomes a white elephant to feed as there is drastic fall in output. Such an inadequacy could be calamitous if highly skilled technical persons leave their job. There can be "critical area collapse" in an organisation.
Quite often, in a hurry of getting manpower, the quality is compromised. Such employees not only underperform, but also necessitate handholding and supervision for indefinite time.
With timelines to observe, there is work reallocation - invariably punishing the competent and sincere employee. This leads to strained interpersonal relationships and rivalries - another enemy of teamwork. It is for human resources department (HRD) to ensure that selection of candidates is befitting the requirement of job. Also, they must not get the manpower by "by hook or crook." If a mediocre joins with help of a hook, he will himself stagnate in his job. Worse, he may even stagnate the job assigned to him. If an employee is obtained by crook, rest assured that sometime this crook will leave your company in lurch by leaving you at a critical time.
While selecting a candidate, the reputation of the institute must be valued rather than the label of his diploma. There are always credible teaching institutes and "run-of-the-mill." The preliminary scrutiny of applications should carefully weed out entries from the wrong school.
While judging the experience of a candidate, more importance should be given to track record than the years of experience. There are certain traits of a right candidate, though this may not be laid down. They may include:
● Abilities to perform tasks to precision
● Minimal need of supervision
● Alertness for deviations from norms
● Quality consciousness
● Attending the assignments without overlooking the broad objective
● Being a team-member
● Rising to an occasion
Technical experts quite often feel that they should work only in their small specialised field and they should be insulated from administration or other managerial issues. Such luxury is not affordable in the twenty-first century. With frequent and fast changes in the external environment, there is extreme interdependence and overlap between various departments of any organisation. Compartmentalisation of a job on hand is just not possible. Also, irrespective of the title held by an employee, it is inevitable that everyone will be required to be ready for multi-tasking. Otherwise "not my job" excuse can prove detrimental to the organisation. It is necessary that the induction training should pay special attention to this aspect.
Recent trend is to incorporate "principles of modern management" in the curriculum of the post-graduate diploma or degree. It is an essential component of a finishing school. The training in managerial sciences should provide broad context. But more important is relevance of those topics to his day-to-day working and their importance in team work. It needs careful curriculum design and interactive learning with live situations. Case studies from the organisations can contribute to the induction training. Therein the organisation's history - with its success and failure stories - can be shared.
"On job training" has the most important component of hand-holding by immediate supervisor. It is well known that maximum mistakes are made and accidents are committed by an employee during his first year of service. This is particularly true if this is ones first job. The supervisor has to be supportive and should keep in mind that he/she too was a novice sometime.
An important aspect of corporate need and job satisfaction of an employee is continued education. It cannot be left to HRD alone. If a line manager desires 'adequate' manpower, the right way is to get the best out of an employee and to tap his potential to his best. For this the operations side and HR must sit together and plan for a tailor made corporate training programme that will have distinct value addition to the skills of employee. Also, it must translate in better productivity.
Inadequacy of qualified manpower also has the inevitable companion of high attrition rate, with a start up CRO 'poaching' experienced manpower en-bloc, leaving the victim organisation in duress. The reasons for high attrition are well documented. In essence, it is the ethos of the organisation that determines if your colleagues will leave the comfort zone of a job in hand and land in an insecurity easily. It is not money alone; it is the future that an employee envisions with the growth of the organisation and his career path matching.
The essence of matchmaking is to find the right guy with whom it will be pleasure to be for long years. It is no different in human resource management.
(The author is the Director and Dean of Clinical Research Education and Management Academy, Mumbai)