There was a long back time when we was thinking that whether career in CR will provide better prosperous life to medical and paramedical professionals as compare to other lifescience fields.
So we, pharmatutor, are appearing with some important facts and career blasting opportunities to you.
What is Clinical Research?
A clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or contract research organizations (CRO's) on their behalf. It is this sector that is driving the growth in clinical research in India.
As you know, it is conducted in 4 phases and in all these various phases requires number of medical and paramedical professionals.
- On average, pharma companies are spending anywhere between $100 and $800 million per drug candidate.
- They always looking for place where they get maximum cost effective benefits and that’s why only the India is best hub for clinical research.
1. Clinical Research Associate: Clinical Research branches off into various categories at the entry level. The most common entry-level position is that of a Clinical Research Associate (CRA).
The role of a CRA is varied,
* They are key participants in the design, implementation and monitoring of clinical trials
* They shoulder the responsibility of planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Clinical Practices are followed.
* They assist in preparation of presentations and manuscripts of scientific meetings and technical journals and attend scientific/professional meetings and training courses as appropriate.
2. Biostatisticians are those who,
* Perform statistical programming, design, and analysis for clinical trial projects. Planning, coordinating and providing statistical analyses, summaries and reports of studies is also a part of their job profile.
* In addition they are responsible for New Drug Applications and Biological License Applications submissions.
3. CRM are Clinical Research Managers
* They supervise design and writing of protocols, case report forms and informed consent forms for clinical trials. They ensure that Case Report Forms are reviewed in a timely fashion and submitted to the data management group.
4. Pharmacovigilance Manager
- Providing full service adverse event case management services .
- Ensuring timely & accurate processing of individual reports and safety reporting to regulatory timelines
- Perform other related duties as assigned or requested by the Senior Director.
5. Quality Assurance (QA)
Quality assurance department supremely deals with validation of all aspects of the clinical trial process. In Biotechnology industry, the role of quality assurance specialist is relatively complicated. This includes proper vigilance of safety, efficacy, purity, and stability of end products.
6. Project Manager and Marketing Executives
The and marketing professionals make sure that a particular drug is not only safe and effective but is also cost-effective for efficient disease management.
7. Clinical Investigator
Clinical is generally a physician possessing a license to practice anywhere in the country.
8. Other Jobs
Account Directors: This includes a number of other designations like Business Development Analyst, Clinical Project Director, and Clinical Program Manager. A degree in Life Sciences and interest in medical writing and pharmaceutical marketing is a must.
Clinical Auditors: This includes GCP specialist and QA auditors. A graduate level qualification in Life Sciences with a strong knowledge about GCP, GMP, GLP auditing processes.
Contract Managers: This includes Contract Associates, Senior Proposal and Contract Managers, and Senior Project Managers. One must possess a bachelor's degree in life sciences with work experience in proposal writing and thorough understanding of complete clinical development process.
Drug Safety Scientist: This includes Drug Safety Monitor, Drug Safety Officer, Drug Safety Associate. A masters degree in Life Sciences/Pharmacology with good experience in medical writing, computers, regulatory requirements, drug information and other clinical processes.
Regulatory Affairs Manager: This includes Senior Regulatory Associates, Manager (Regulatory Affairs) etc. A graduate degree in Life Sciences, Clinical research experience and knowledge of FDA requirement is a must.
There is high demand for trained professionals in this field; the pay package is impressive at the entry level.
* Fresher's can expect a pay packet of around 3 lakhs or more per annum.
* If you have a master's degree backing your qualifications, then the amount is almost doubles.
* Clinical research is an industry where experience counts, thus the longer you are in this field; higher the salary you can expect.
There are various growth opportunities along the way for those willing to learn. For those interested in serious research work, a PhD is the ideal solution. There are post graduate degrees and diplomas offered by various colleges which come in handy to enhance one's career prospects. Specialization in branches of pharmacy, life sciences, biochemistry will be useful.
Studying further will also help one in bettering their current job profile. For instance doing masters will enhance the job prospects of a CRA to become a Project Manager. Similarly a PhD in a related discipline is needed to become a Medical Director. According to industry reports, India is the second largest pharmaceutical market in Asia growing by more than nine per cent annually. According to a report, there are more than 50,000 jobs in clinical research in India .Lack of experience is no longer a hindrance, and companies are hiring from other streams too. With the influx of multinationals setting up research facilities here, the industry is poised to grow exponentially.
Few Companies which hiring CR Professionals:
• Accutest Research (I) Pvt. Ltd.
• Intas Pharmaceuticals Ltd.
• Icon Clinical Research (I) Pvt. Ltd.
• Abbot India Ltd.
• Johnson & Johnson
• Aventis Sanofi
• Kendle (I) Pvt. Ltd.
• Accenture Services Pvt. Ltd.
• Lambda Therapeutic Research Ltd.
• Aurigene Discovery Technologies
• Lupin Ltd.
• Asian Clinical Trials Pvt. Ltd.
• Leelavati Research Centre
• Alkem Labs Ltd.
• LG Life Sciences India
• Ace Biomed
• Emcure Pharmaceuticals Ltd.
• Shreya Life Sciences
• Metropolis Health Services (I) Pvt. Ltd.
• Atlanta Pharma Pvt. Ltd.
• Nicholas Piramal (I) Ltd.
• Ajanta Pharma Ltd.
• Aristo Pharmaceuticals Ltd.
• Novo Nordisk (I) Pvt. Ltd.
• Astra Zeneca India
• Neeman Medical Intl Ltd.
• Apothecaries Ltd.
• Appolo Spectra
• Bayer India Ltd.
• Cadila Pharmaceuticals Pvt. Ltd.
• Global Spectrum Clinical Research USV Ltd.
• Eli Lilly & Company (I) Pvt. Ltd.
• Pharmanet India
• Claris Lifesciences Ltd.
• Cipla Ltd.
• Panacea Biotech Ltd.
• Clinworld International.
• Quintiles Research (I) Pvt. Ltd.
• Cognizant Technologies Solutions (I)
• Pvt. Ltd.
• Ranbaxy Ltd.
• Clinigene International
• RPG Life Sciences Ltd.
• Clinsearch Labs
• Siro Clinpharm Pvt. Ltd.
• Clininvent Research
• Sun Pharma
• Dr. Reddy's Laboratories Ltd.
• SRL Ranbaxy
• Dabur Research Foundation
• Serdia Pharma
• E Merck
• Somex Research & Health Private Ltd.
• Synapse Labs Pvt Ltd.
• Fulford (I) Ltd.
• Suven Life Sciences Ltd.
• German Remedies
• Tata Memorial Hospital
• Glenmark Laboratories Pvt. Ltd.
• Torrent Pharmaceuticals Ltd.
• Glaxo (GSK)
• Unichem Laboratories Ltd.
• GVK Biosciences
• Veeda Clinical Research India
• iGATE Clinical Research Intl.
• Wyeth Leaderle
• HCL Technologies
• Wockhardt Ltd.
HOW WILL YOU ENTER IN THIS NOBEL PROFESSION?
You require special clinical institute which gives you better knowledge with 100% placement assurance.
There are many CR Institutes but we searched for the best one. We did many surveys and also ask CR professionals about their experience with such organizations.
We find some one which is in many fields like Science & Innovation, bioPharmaceuticals, bioNutrition, bioAgriculture etc.
PG Diploma In Clinical Research, Pharmacovigilance, Regulatory And Clinical Data Management