Career Prospects In Clinical Research by Amrita Bhattacharya

Introduction

Clinical Research is a billion dollar booming industry which is growing at an amazing rate and hence opening up a wide scope of employment opportunities for trained professionals. The industry is seeking high demand for qualified professionals from pharma and life-science sectors. MBBS, MD Doctors, Pharmacy graduates and post graduates, Life-science graduates and post graduates can make clinical research as an interesting career with a great scope of professional growth. To build a career in clinical research basic education in this field is necessary. There are many institutions through which students are doing PG Diploma and MSc courses in clinical research and getting good jobs with good package in pharmaceutical industries. Basic knowledge of Drug Development Process, Clinical Trial Design & Statistics, Regulatory and Ethical codynamics and Pharmacokinetics is required for getting involved in the field of clinical research which is being taken care of various institutions who are providing certification courses to students who want to start a career in clinical research.

Clinical research in brief

Before stepping into what career opportunities prevail in clinical research let us understand a few basics of clinical research. Clinical Research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens for humans. It is an applied research. Clinical research brings the latest therapies and pharmaceuticals from the laboratory bench to the bedsides of real patients. The discipline blends two-different worlds-the laboratory and the clinic and translates basic discoveries into treatments for human disease. Clinical research is generally divided into 4 phases. Phase I being carried out on healthy volunteers determines the safety profile of the drug and observes how the body responds to drug. Phase II and III is carried out on patients and determines the efficacy that is weather the treatment actually works or not as well as safety of the drug. Phase IV is post marketing surveillance which basically focuses on the scenario when the drug is actually launched into the market. There are several guidelines which needs to be followed in this field and are the backbone for carrying out the clinical trials such as ICH-GCP guidelines, Indian GCP guidelines, ICMR guidelines on Biomedical research, USFDA guidelines, EU Directives being the important ones as well as one needs to follow the regulations of particular country in which the drug product is desired to be launched.

Why to choose a career in clinical research

It's part of the Fastest Growing Industry in India and World which is expected to grow US$ 280 billion by 2020. With many of the Indian companies entering global markets for e.g. Aurobindo Pharmaceuticals, Cipla etc, they need trained professionals who can handle their Pharmacovigilance and Clinical Research Activities. As of now the Industry is lacking professionals who have thorough knowledge of clinical research and are trained. The industry is searching for candidates who have the required knowledge, training and skills in order to face the challenges in this field. There are instances where people have entered the industry 5-7 years back and now hold the Manager and Associate Director positions so it is the only industry where there is faster career growth for the desired candidates. Compared to other jobs in healthcare sector this field provides handsome salaries. Salaries given to the Candidates are at par with or sometimes better than what software professionals earn in MNC companies. Global opportunities can be explored with this field. For e.g. in case of multi-centric global trials a candidate will have the chance to go for monitoring visit or audits depending on his/her current profile. A trained professional will have an opportunity to work in a foreign country with the client depending on projects which is hardly observed in any other healthcare jobs.

Career Prospects in General

As a clinical research trained professional one can have various career pathways ranging from Pharmaceutical Companies to CROs (Contract Research Organizations), BA/BE centers, SMOs (Site Management Organizations), IT companies in Healthcare/Clinical Domain, EDC (Electronic Data Capture) Service Providers, Medical writing companies, Central Laboratories, Training centers etc.

The Career prospects for a trained CR professional in SMOs/CROs/Pharma/Biotech Companies include but not limited to Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Clinical Research Coordinators, Principal/ Co-Investigators, Clinical Team Leader, Project Manager, Quality Assurance Auditor, Medical Director, Medical Writing Professional, Medical & Regulatory Affairs Professional, Business Development Professional, Director/Head (Clinical Operations). Career prospects with respect to Data Management involve Data Entry Operator, Data Validation Executive, QA, Data Manager, Data Reviewer, Database Designer, Statistical Programmer, Statistician, Head (Data Management). Another area which is fast growing now a days is Pharmacovigilance where one can start with a position of a drug safety associate, officer, scientist or coordinator. Responsibilities will then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area such a medical writing, auditing, medical affairs or quality assurance.

Career Prospects by Profession

MBBS/MD/BHMS/BAMS doctors can get associated as Principal Investigators/Co-investigators/Medical Advisor/Drug Developers/Regulatory Affairs Manager/Head (Medical Writing). Companies involved in Pharmacovigilance typically prefer to hire doctors as it requires assessing AEs, SAEs, and ADRs. Pharmacists and Life Science Graduates/Post Graduates can get involved as Medical writers/Clinical Research Associates/Site Coordinators/Clinical Research Coordinators/Drug Development Associates/ Clinical Data Management/ Pharmacovigilance Executives/ Clinical Trial Analysts/ Clinical Research Associates/ Quality Assurance Auditors/R& D scientists. For those holding management degree along (with Life Science/Health Science background), they can directly start in Business Development domain, Clinical Project Management/ Regulatory Affairs. As compared to wide variety of options available in this field there is hardly any other field where a candidate has so many options to get associated with.

Remuneration

At an entry level as a fresher one can earn between INR 10K-20K monthly according to different industry standards. After having 2 years of experience one can start earning between INR 25K-40K monthly according to profile in which he/she is working and get promoted simultaneously to a senior level. After 3 years of experience an INR between 35K-60K monthly can be earned and one can work as middle managerial positions. A professional having 5-7 years of experience can earn between INR 80K-1 lakh monthly and can work at senior managerial positions. After gaining almost 7-10 years of experience one can easily earn somewhere between INR 2-3 Lakhs monthly and can work as a Director/Vice-president in various organizations. However although the above mentioned figures denote how much one can earn approximately, it again depends from industry to industry.

Top 10 global CROs 2018

LabCorp (Covance), Quintile IMS Holdings Inc, Syneos Health, Parexel International Corporation, PRA Health Sciences, PPD, Charles River Laboratories Inc (CRL), ICON Public Limited Corporation, Wuxi Apptec, Medspace Holdings, Inc.

Other than these top 10 global CROs there are a number of other pharmaceutical companies and CROs like Accutest Research Laboratories, Asian Clinical Trials Pvt Ltd, Clinigene International, Clininvent Research, Kendle India, Siro Clinpharm, Sanofi Aventis, Aurega Research Ltd, Indegene, APCER Pharma, Novartis, Pfizer etc to name a few.