The Drug Development Cycle is a vast area in which you have many job opportunities.
Clinical Research in itself, which is a small part of the drug development cycle,
is a field with many options for a life science graduate and Medical graduates.
Within the limited area of Clinical Research are opportunities lurking at every
The studies conducted to evaluate the quality, safety and efficacy of investigational
products, be it drugs, biological, medical devices or medical procedures on humans
in a strictly scientifically controlled setting is termed as Clinical Research.
Here are a few options you can consider :
- Clinical Research Associate (CRA)
- Clinical Research Coordinator (CRC)
- Scientific writer
- Quality Analyst (Quality Assurance and Quality Control)
- Data Manager
- Data Validator
- Data Entry Operator
A CRA mainly deals with administering and monitoring the progress of a Clinical
Trial. A CRC, as the name suggests, coordinates the trial at the site. A CRC assists
the Investigator in the trial procedures. The Investigator is a person (Doctor)
responsible for the conduct of the study at the trial site. Investigator is responsible
for the rights, health and welfare of the study subjects.
Scientific writers are the people who prepare documents like the Protocol, which
assists in regulatory approvals for the conduct of the trial. Biostatistician is
a person who is knowledgeable in the field of mathematics and applies it to the
biological systems. The role of a biostatistician in the field of Clinical Research
is to analyze the data collected from the trial. Quality Analysts ensure that the
maintenance of quality throughout the conduct of the trial.
A Data Manager monitors the entire process of data management, right from the entry
of data to the final analysis. Data Entry Operator transfers the data on the Case
Report Forms to a database for further analysis while a Data Validator is one who
ensures that the data collected during a trial is clean and not corrupt in any way.
For the above job profiles, you may be directly employed by pharmaceutical companies
or hired by contract research organizations. You may be working for individual data
management units or hospitals.
Typically, Investigators, CRAs and CRCs are hired by Contract Research Organizations.
Scientific writers and biostatisticians are hired by Pharmaceutical companies while
Data Management units hire Validators and Data Entry Operators. Hospitals also hire
Graduate or a Postgraduate in any of the following streams: Pharmacy (B.Pharm, M.Pharm),
Medicine (MBBS, MD), Dentistry (BDS, MDS), Physiotherapy (BPT, MPT), Homeopathy
(BHMS), Nursing, Microbiology, Biotechnology, Biochemistry, Lab science, Genetics,
Nutrition, Botany, Zoology.
- The Drug safety industry ranks among the fastest growing industries.
- More than 6 out of 10 workers have a bachelor’s, masters, professional, or Ph.D.
degree—twice the proportion for all industries combined.
- Fifty-nine percent of all jobs are in large establishments employing more than 500
- Earnings are much higher.
- There is a high demand for qualified individual and that the demand is expected
- Depending on the company and level of sophistication those with MBBS, MD, BSN, RN,
PHARM.D, BDS, can apply.
- Positions are available all over USA in Hospitals and Pharmaceutical companies for
data entry, interviewing patients, writing case narratives and handling details.
- Review case and medical records. For the case report, making sure the story is medically
sound and proper terminology is used. Contacting physicians with detailed questions
about Individual cases.
- Processing safety reports into drug safety databases. Information in the databases
can be searched and aggregated to determine whether a previously unrecognized safety
issue has arisen.
- Reviewing the data in the drug safety database and if a new event has been reported
, meeting with the drug development team for labeling changes.
In addition to skills and traits of those who do well in clinical development, people
who flourish in drug safety carrier tend to have.
Good clinical judgment and sound medical knowledge about the pathology of a disease.
Good and sound knowledge about the pharmacology of the drugs.
The ability to distinguish the most relevant point from irrelevant ones. Most of
the drug safety cases are not product related most of them these are drug- drug
A mixture of activity provides a job variety
If the quality of life is important to you this is a great career. It can be a 8
to 5 job with little or no travel. You are not on call or when you leave at the
end of the day your work stays at the office.
The job fills an imp need for the society. You are contributing to the safe use
of the drug and affecting public life on a grand scale.
There is much autonomy and these positions carry decision making authority.
Those with drug safety experience are in high demand and exceptionally good job
security. And the demand is expected to grow!
These positions pay well. Those in drug safety are generally are paid more than
those in hospitals or pharmacies with comparable level of experience.
Graduate or a Postgraduate in any of the following streams: Medicine (MBBS, MD),
Nursing, Pharmacy (PHARM.D; B.Pharm, M.Pharm), BDS.