Interview questions for Clinical Data Management for fresher

Clinical data management is one of important domain in clinical research. All data coming from clinical research is validated by clinical data management.

Clinical data management jobs provided by various CRO (contract research organization) , healthcare IT firm and some sponsored organizations also.

There are multiple rounds in an interview such as walk in , in person interview. In walk interview there are different rounds such as aptitude test, group discussion etc. In person interview had different rounds such as HR round and technical round.

Today we will discuss about various interview questions which will ask for interview for freshers

Q. Tell me something about yourself.
Hi Sir/mam, GM/GA
e.g.- My name is Yogita. I leave in Mumbai. I have done my B-pharm from Amravati
university and M- pharm from Pune university with first class. I have done my
specialization ‘Pharmaceutics’. I am a fresher and eagerly looking for job.
I haver mother and Father in my family. In hobby I like to watch motivational and
health related videos on U-tube as well as love travelling.
Q. What are your strengths and weaknesses?
Strength – Hardworking, honest and self-motivating, positive attitude
Weakness – I trust people easily and can’t say no when anyone asks me for help
Q. Do you have any questions for us?
Include thanks to interviewer. Ask working hours, training periods, job location,
transport. At last just ask interviewer ‘Any feedback or suggestion for me’ also ask
for areas of improvement.
Q. What are your salary expectation?
As a fresher, I expect the salary as per company norms or policy.
Q. What are your career goals?
To utilize my skills and improve my professional career in reputed pharmaceutical
company. To get respectable position in any company.
Q. What do you know about this company/organization?
Read respective company information on Google. Tell them history, direction,
progress, branches, culture and product of company.
Q. Why do you want to work here?
It will be a great privilege for me to work in a reputed company like this.
Q. How did you hear about this position?
From social media, friends
Q. What is CDM?

Clinical Data Management (CDM), or Clinical Data Management System (CDMS), is
used in clinical research to manage the data of a clinical trial.
Q. What are CDM skills?
The skills needed to become a clinical data manager include: Excellent
communication skills, both written and verbal. Project management skills.
Q. What are CDM activities in clinical trials?
Clinical trial data management (CDM) is the process of a program or
study collecting, cleaning, and managing subject and study data in a way that
complies with internal protocols and regulatory requirements.
Q. What is the scope of CDM in India? (just for information)
Professionals with Clinical Data Management course can make anywhere between
INR 3 Lakh to INR 11 lakhs in India. The highest salary of a Clinical Data Manager is
₹11,22,503 per annum and the lowest salary for a Clinical Data Manager in India is
₹3,16,980 per annum.
Q. What are the role of Clinical Data Manager?
Responsibility of Data Manager is to collect and analyse data from a wide range of
medical research projects such as clinical trials and pharmaceutical trials.
Q. Why are interested in our company?
Your company has always been an admiration of mine. Therefore, I read all your
posts on social media. I am familiar with your companies’ rules and regulations, and
I like how you take care of your employee and manage the company. I am
interested in joining your team, and I promise to work smart and collaborate with
my teammates.
Q. What is a clinical trial?
CT are generally considered to be biomedical or health-related research studies in
human beings that follow a pre-defined protocol.
Q. What is AE and SAE?
Adverse event: An undesired effect of a drug or other type of treatment, such as
surgery.
Serious adverse event: A serious adverse event or reaction is any untoward
medical occurrence that at any dose resulting in: Death. Life-
threatening. Hospitalization (initial or prolonged) Disability or Permanent Damage.

Congenital Anomaly/Birth Defects. Other Serious or Important Medical Events.
Required Intervention to Prevent Permanent Impairment/Damage.
Q. What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before
deciding whether or not to participate. It is also a continuing process throughout the
study to provide information for participants. To help someone decide whether or
not to participate, the doctors and nurses involved in the trial explain the details of
the study.

Q. What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully
designed to safeguard the health of the participants as well as answer specific
research questions.
Q. What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value.
Q. What are the phases of clinical trials?
 In Phase I trials, researchers test an experimental drug or treatment in a
small group of people (20-80) for the first time to evaluate its safety,
determine a safe dosage range, and identify side effects.
 In Phase II trials, the experimental study drug or treatment is given to a
larger group of people (100-300) to see if it is effective and to further
evaluate its safety.
 In Phase III trials, the experimental study drug or treatment is given to
large groups of people (1,000-3,000) to confirm its effectiveness,
monitor side effects, compare it to commonly used treatments, and
collect information that will allow the experimental drug or treatment to
be used safely.
 In Phase IV trials, post marketing studies delineate additional
information including the drug’s risks, benefits, and optimal use.
Q. Explain Clinical Research.
Clinical research refers to any kind of investigation in human subjects which aims to
discover or check the clinical, pharmacological, and other pharmacodynamic effects
of an investigational product.

Q. What are the 3 stapes of CDM?
Set-up, Conduct and close-out

Q. What is pharmacology?
Pharmacology is a branch of science that deals with drugs. Or the study of
pharmacokinetics and pharmacodynamics.
Q. What is pharmacokinetic?
ADME – absorption, distribution, metabolism, excretion. pharmacokinetics means
What the body does to the drug.
Q. What is pharmacodynamics?
Pharmacodynamics means what the drug does to the body.
Q. How many systems present in body?
1. Nervous system
2.  Skeletal system
3.  Muscular system
4. Respiratory system
5. Digestive system
6. Circulatory system
7. Reproductive system
8. Excretory system
9. Urinary system
10. Lymphatic system
11. Integumentary system
Q. What are the different therapeutic areas?
1.Dermatology
2.Oncology
3.Neurology
4.Immunology
5.Rheumatology
6.Ophthalmology
7.Respiratory
8.Endocrine
9.Cardiovascular
Q. What is Bio-availability?
It is the amount of active drug present in circulation. It is expressed in percentages.

Q. How many route of administration present?
Oral, Parenteral, topical, Nasal.
Q. What are ICH GCP guidelines?
The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is
an internationally agreed standard that ensures ethical and scientific quality in
designing, recording and reporting trials that involve human subjects.
GCP- Good Clinical Practice (GCP) is a set of internationally recognised ethical and
scientific quality requirements that must be followed when designing, conducting,
recording and reporting clinical trials that involve people.
Q. What is 21 CFR Part 11 in clinical trials?
21 CFR Part 11 contains requirements to assure the agency that electronic
signatures are the legally binding equivalent of a person’s handwritten signature.
Note- Apart from these questions you must have basic knowledge about your
degree.
e.g. if you done B-pharm then u have knowledge about all the basic terms.
That is different types of drug/ capsule, interaction of drugs, guidelines,
pharmacology, microbiology, organic/inorganic chemistry.
Interweaver mostly ask question on your degree/PG because you are fresher and
not having any experience about any field/domain.

All the best