Cs
o
co
an
CD
po
S
(An aut
linical Develo
ociety to prov
ountry’s grow
nd facilitate tra
DSA invites app
ositions for spo
S.No Name o
/ Emo
SENIO
RESEA
OFFICE
(1 posi
Up to R
53,680
month
(conso
RESEAR
OFFICER
(Data
Manage
(1 posit
Up to R
43,489/
month
(conso
An
tonomous ins
pment Service
vide cost effec
wing healthcar
anslation of scie
plications from h
onsored researc
of the post
oluments
R
ARCH
ER
ition)
Rs.
0/‐ per
h
olidated)
Q
M/
M
ac
wt
e
(P
NF
o
Pe
Gr
e
d
SK
RCH
R
ement)
tion)
Rs.
/‐ per
lidated)
QAs
c
SK
C
extramural u
titute of the D
47
es Agency (CD
ctive, high qu
re needs. It w
entific know‐how
high‐performin
ch projects:
Qualifications
QUALIFICATIONS
MBBS degree / M
MSc Nutrition f
ccredited Indian
with 2‐3 years re
eaching experie
Pediatrics / Obs
Nutrition).
or MD/DNB/Dip
ediatrics or Obs
Gynecology one
esearch experie
esirable.
KILLS:
High level of
computer lite
Ability to writ
papers for pe
journals.
Ability to writ
to national an
international
funding..
Good admini
time‐manage
to meet dead
Good commu
skills both wr
oral
QUALIFICATIONS
A bachelor’s deg
cience or relate
KILLS:
Knowledge o
Clinical Pract
research, Clin
process and r
regulatory re
and terminol
Working expe
clinical datab
such as Oracl
Clintrial, Med
Thorough un
of clinical dat
management
methodology
CLINCIAL DEVE
nit of Transla
Department o
0 Udyog Viha
DSA) is an ext
ality preclinic
will tend ente
w into viable pr
g professionals
s and Skills
S:
MPharm
rom an
n University
esearch or
ence
stetrics /
ploma in
stetrics &
year of
ence is
general
eracy
te research
eer‐reviewed
te proposals
nd
agencies for
strative and
ement ability
dlines.
unication
ritten and
S:
gree in
ed area.
of Good
ices, Clinical
nical trial
related
equirements
ogy
erience of
base systems
le Clinical,
didata Rave.
derstanding
ta
t
y
ELOPMENT SE
tional Health
of Biotechnolo
r, Phase III, G
ramural unit o
cal and clinica
rprises ‐ parti
roducts.
with a desire t
Expe
2‐3 years expe
research for m
graduates / M
Nutrition and
PG degree in P
Obstetrics & G
2‐5 years expe
clinical data m
activities
ERVICES AGEN
Science & Te
ogy, Min of Sc
urgaon – 122
of THSTI and
l product dev
icularly SMEs
o serve public h
erience
erience in
medical
MPharm / MSc
one year for
Pediatrics or
Gynecology
erience in
management
NCY
chnology Inst
cience & Techn
‐016
has been esta
velopment sup
involved in n
health needs of
Prepare
describin
both con
Interact
with oth
within in
academi
Contribu
develop
applicat
Monitor
complia
the proje
evaluate
Contribu
in order
to help r
profile.
Be inform
field of b
and the
Participa
conduct
perform
Provide
support
Lead Dat
projects
Develop
(DMP), m
lifecycle
DMP is f
design a
Develop
data spe
query lo
Ensure d
perform
GCP and
Coordina
database
Data rec
discrepa
titute
nology, Govt.
ablished as a
pport services
new technolog
f the country fo
Job profile
reports and pa
ng the results o
nfidential and fo
positively and p
her collaborator
ndustry/comme
ia.
ute proactively
ment of extern
ions
r the trial progre
nce with and ad
ect plan and to
e and rectify pro
ute to organizat
to help it run s
raise its externa
med of develop
both technical/s
wider subject a
ate in developm
ing appraisals a
ance reviews a
Clinical data ma
to study projec
ta Manager on
ps Data Manage
maintains DMP
of study projec
followed accord
and requiremen
p database (DB),
ecifications, edit
ogic and data va
data processing
ed according to
d SOPs
ate the archivin
es and related d
conciliation/Rev
ancies
of India)
not‐for‐profit
s to meet the
gy innovation
or the following
pers
of the research,
or publication.
professionally
rs and partners
erce and
to the
al funding
ess to ensure
dherence to
identify,
oblems.
tional matters
moothly and
al research
pments in the
specific terms
area.
ment of staff by
and
nd training
anagement
ct and act as
assigned
ement Plan
throughout
ct and ensures
ding to study
nts
, clinical trial
t checks,
alidations
g activities are
o protocol,
ng of study
documents
view of
Knowledge of clinical
database design
Project coordination
Familiarity with standard
coding dictionaries
Strong communication
skills, both written and
verbal
Write and resolve data clarifications
Quality Check of Database Design,
Validation Program, Annotated CRF,
Data Extract Views, Laboratory
Details, Site and Investigators and
Final Data Listings
Performs other data cleaning and
database lock activities as assigned
Participates in study team meetings
as DM representative
RESEARCH
NURSE/COORDINATOR
(Two positions)
Up to Rs.27,397
per month
(Consolidated)
QUALIFICATIONS:
Bachelor's degree in
healthcare or other
related discipline or
equivalent combination
of education, training and
experience or
diploma/post graduate
degree in Clinical
Research.
SKILLS:
Computer skills including
proficiency in use of
Microsoft Word, Excel
and PowerPoint
Strong written and verbal
communication skills
including good command
of English language
Ability to establish and
maintain effective
working relationships
with coworkers,
managers, investigators
and sponsors.
Experience of 1‐2 years
with basic knowledge of
applicable clinical research
regulatory requirements;
i.e., Good Clinical Practice
(GCP) and International
Conference on
Harmonization (ICH)
guidelines
Perform site selection, initiation,
monitoring and close out visits in
accordance with contracted scope of
work and good clinical practices.
Administer protocol and studyrelated
training to assigned sites and
establish regular lines of
communication with sites to manage
ongoing project expectations and
issues.
Evaluate the quality and integrity of
study site practices related to the
proper conduct of the protocol and
adherence to applicable regulations.
Escalate quality issues to Project
Manager.
Manage the progress of assigned
studies by tracking regulatory
submissions and approvals,
recruitment and enrollment, Case
Report Form (CRF) completion and
submission, and data query
generation and resolution.
Under close supervision, create and
maintain appropriate documentation
regarding site management,
monitoring visit findings and action
plans by submitting regular visit
reports and other study‐related
documentation.
DATA ENTRY
OPERATOR
(1 position)
Up to Rs.
18,360/‐ per
month
(consolidated)
QUALIFICATIONS:
A Bachelor’s degree in
science or related area.
SKILLS:
Proficiency in Microsoft
Word & Excel
Ability to work cohesively
in a team
1 ‐ 3 years experience in
clinical data management
activities with technical
knowledge of ICH –GCP and
of Data Management
processes and systems
Receiving Case Report Forms (CRFs)
and entering the data into clinical
databases ensuring accuracy
Identifying and resolving data
discrepancies
Update/correct/review data in the
clinical databases based on resolved
data queries
Participate in data validation
Assist with the testing of data entry
screens and the preparation of the
relevant testing documentation.
Create and maintain study files and
other appropriate trial specific
documentation
Note: The statements made in the job descriptions are intended to describe the general nature and level of work
being performed by person assigned to this job. These statements are not intended to be an exhaustive list of all
responsibilities, duties and skills required of people assigned to this job.
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board / University.
2. The experience requirement specified shall be experience acquired after obtaining the minimum
educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the
time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the
controlling authority, in case candidates are otherwise well qualified.
5. Interested candidates may please send their current CV in the attached form entitled “Employee
Biographical Data Sheet with a cover letter and three references by e‐mail to cdsa_admin@thsti.res.in
Applications will be accepted up to 15th February 2013.
6. In case a large number of applications are received for each post, screening will be done to limit the
number of Candidates to those possessing higher/relevant qualification. Only shortlisted candidates
will be contacted for further discussion.
7. Above mentioned positions do not fall under the Contract Career Path of CDSA and are for sponsored
research projects. Appointment will be initially for one year and extendable till the duration of the project
based on the performance.
8. The salary is a consolidated sum without any other benefits. Salaries mentioned against each position are
indicative and actual salary will be based on experience, qualifications, skill set etc. of the candidates.
9. Positions will be initially based in the CDSA’s interim office at Gurgaon and will be shifted to its
permanent campus in Faridabad when ready.
10. Number of positions filled will be as per the need and availability of suitable candidates.
11. Canvassing in any form will be a disqualification.
o
co
an
CD
po
S
(An aut
linical Develo
ociety to prov
ountry’s grow
nd facilitate tra
DSA invites app
ositions for spo
S.No Name o
/ Emo
SENIO
RESEA
OFFICE
(1 posi
Up to R
53,680
month
(conso
RESEAR
OFFICER
(Data
Manage
(1 posit
Up to R
43,489/
month
(conso
An
tonomous ins
pment Service
vide cost effec
wing healthcar
anslation of scie
plications from h
onsored researc
of the post
oluments
R
ARCH
ER
ition)
Rs.
0/‐ per
h
olidated)
Q
M/
M
ac
wt
e
(P
NF
o
Pe
Gr
e
d
SK
RCH
R
ement)
tion)
Rs.
/‐ per
lidated)
QAs
c
SK
C
extramural u
titute of the D
47
es Agency (CD
ctive, high qu
re needs. It w
entific know‐how
high‐performin
ch projects:
Qualifications
QUALIFICATIONS
MBBS degree / M
MSc Nutrition f
ccredited Indian
with 2‐3 years re
eaching experie
Pediatrics / Obs
Nutrition).
or MD/DNB/Dip
ediatrics or Obs
Gynecology one
esearch experie
esirable.
KILLS:
High level of
computer lite
Ability to writ
papers for pe
journals.
Ability to writ
to national an
international
funding..
Good admini
time‐manage
to meet dead
Good commu
skills both wr
oral
QUALIFICATIONS
A bachelor’s deg
cience or relate
KILLS:
Knowledge o
Clinical Pract
research, Clin
process and r
regulatory re
and terminol
Working expe
clinical datab
such as Oracl
Clintrial, Med
Thorough un
of clinical dat
management
methodology
CLINCIAL DEVE
nit of Transla
Department o
0 Udyog Viha
DSA) is an ext
ality preclinic
will tend ente
w into viable pr
g professionals
s and Skills
S:
MPharm
rom an
n University
esearch or
ence
stetrics /
ploma in
stetrics &
year of
ence is
general
eracy
te research
eer‐reviewed
te proposals
nd
agencies for
strative and
ement ability
dlines.
unication
ritten and
S:
gree in
ed area.
of Good
ices, Clinical
nical trial
related
equirements
ogy
erience of
base systems
le Clinical,
didata Rave.
derstanding
ta
t
y
ELOPMENT SE
tional Health
of Biotechnolo
r, Phase III, G
ramural unit o
cal and clinica
rprises ‐ parti
roducts.
with a desire t
Expe
2‐3 years expe
research for m
graduates / M
Nutrition and
PG degree in P
Obstetrics & G
2‐5 years expe
clinical data m
activities
ERVICES AGEN
Science & Te
ogy, Min of Sc
urgaon – 122
of THSTI and
l product dev
icularly SMEs
o serve public h
erience
erience in
medical
MPharm / MSc
one year for
Pediatrics or
Gynecology
erience in
management
NCY
chnology Inst
cience & Techn
‐016
has been esta
velopment sup
involved in n
health needs of
Prepare
describin
both con
Interact
with oth
within in
academi
Contribu
develop
applicat
Monitor
complia
the proje
evaluate
Contribu
in order
to help r
profile.
Be inform
field of b
and the
Participa
conduct
perform
Provide
support
Lead Dat
projects
Develop
(DMP), m
lifecycle
DMP is f
design a
Develop
data spe
query lo
Ensure d
perform
GCP and
Coordina
database
Data rec
discrepa
titute
nology, Govt.
ablished as a
pport services
new technolog
f the country fo
Job profile
reports and pa
ng the results o
nfidential and fo
positively and p
her collaborator
ndustry/comme
ia.
ute proactively
ment of extern
ions
r the trial progre
nce with and ad
ect plan and to
e and rectify pro
ute to organizat
to help it run s
raise its externa
med of develop
both technical/s
wider subject a
ate in developm
ing appraisals a
ance reviews a
Clinical data ma
to study projec
ta Manager on
ps Data Manage
maintains DMP
of study projec
followed accord
and requiremen
p database (DB),
ecifications, edit
ogic and data va
data processing
ed according to
d SOPs
ate the archivin
es and related d
conciliation/Rev
ancies
of India)
not‐for‐profit
s to meet the
gy innovation
or the following
pers
of the research,
or publication.
professionally
rs and partners
erce and
to the
al funding
ess to ensure
dherence to
identify,
oblems.
tional matters
moothly and
al research
pments in the
specific terms
area.
ment of staff by
and
nd training
anagement
ct and act as
assigned
ement Plan
throughout
ct and ensures
ding to study
nts
, clinical trial
t checks,
alidations
g activities are
o protocol,
ng of study
documents
view of
Knowledge of clinical
database design
Project coordination
Familiarity with standard
coding dictionaries
Strong communication
skills, both written and
verbal
Write and resolve data clarifications
Quality Check of Database Design,
Validation Program, Annotated CRF,
Data Extract Views, Laboratory
Details, Site and Investigators and
Final Data Listings
Performs other data cleaning and
database lock activities as assigned
Participates in study team meetings
as DM representative
RESEARCH
NURSE/COORDINATOR
(Two positions)
Up to Rs.27,397
per month
(Consolidated)
QUALIFICATIONS:
Bachelor's degree in
healthcare or other
related discipline or
equivalent combination
of education, training and
experience or
diploma/post graduate
degree in Clinical
Research.
SKILLS:
Computer skills including
proficiency in use of
Microsoft Word, Excel
and PowerPoint
Strong written and verbal
communication skills
including good command
of English language
Ability to establish and
maintain effective
working relationships
with coworkers,
managers, investigators
and sponsors.
Experience of 1‐2 years
with basic knowledge of
applicable clinical research
regulatory requirements;
i.e., Good Clinical Practice
(GCP) and International
Conference on
Harmonization (ICH)
guidelines
Perform site selection, initiation,
monitoring and close out visits in
accordance with contracted scope of
work and good clinical practices.
Administer protocol and studyrelated
training to assigned sites and
establish regular lines of
communication with sites to manage
ongoing project expectations and
issues.
Evaluate the quality and integrity of
study site practices related to the
proper conduct of the protocol and
adherence to applicable regulations.
Escalate quality issues to Project
Manager.
Manage the progress of assigned
studies by tracking regulatory
submissions and approvals,
recruitment and enrollment, Case
Report Form (CRF) completion and
submission, and data query
generation and resolution.
Under close supervision, create and
maintain appropriate documentation
regarding site management,
monitoring visit findings and action
plans by submitting regular visit
reports and other study‐related
documentation.
DATA ENTRY
OPERATOR
(1 position)
Up to Rs.
18,360/‐ per
month
(consolidated)
QUALIFICATIONS:
A Bachelor’s degree in
science or related area.
SKILLS:
Proficiency in Microsoft
Word & Excel
Ability to work cohesively
in a team
1 ‐ 3 years experience in
clinical data management
activities with technical
knowledge of ICH –GCP and
of Data Management
processes and systems
Receiving Case Report Forms (CRFs)
and entering the data into clinical
databases ensuring accuracy
Identifying and resolving data
discrepancies
Update/correct/review data in the
clinical databases based on resolved
data queries
Participate in data validation
Assist with the testing of data entry
screens and the preparation of the
relevant testing documentation.
Create and maintain study files and
other appropriate trial specific
documentation
Note: The statements made in the job descriptions are intended to describe the general nature and level of work
being performed by person assigned to this job. These statements are not intended to be an exhaustive list of all
responsibilities, duties and skills required of people assigned to this job.
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board / University.
2. The experience requirement specified shall be experience acquired after obtaining the minimum
educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the
time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the
controlling authority, in case candidates are otherwise well qualified.
5. Interested candidates may please send their current CV in the attached form entitled “Employee
Biographical Data Sheet with a cover letter and three references by e‐mail to cdsa_admin@thsti.res.in
Applications will be accepted up to 15th February 2013.
6. In case a large number of applications are received for each post, screening will be done to limit the
number of Candidates to those possessing higher/relevant qualification. Only shortlisted candidates
will be contacted for further discussion.
7. Above mentioned positions do not fall under the Contract Career Path of CDSA and are for sponsored
research projects. Appointment will be initially for one year and extendable till the duration of the project
based on the performance.
8. The salary is a consolidated sum without any other benefits. Salaries mentioned against each position are
indicative and actual salary will be based on experience, qualifications, skill set etc. of the candidates.
9. Positions will be initially based in the CDSA’s interim office at Gurgaon and will be shifted to its
permanent campus in Faridabad when ready.
10. Number of positions filled will be as per the need and availability of suitable candidates.
11. Canvassing in any form will be a disqualification.