CLINICIAL DEVELOPMENT SERVICES AGENCY
An
extra mural unit of Translational Health Science & Technology
Institute (an autonomous institute under the Department of Biotechnology
(DBT), Ministry of Science & Technology, Govt. of India)
NCR Biotech Science Cluster at Gurgaon-Faridabad Expressway,
Faridabad.
Clinical
Development Services Agency (CDSA) mission is to create, develop,
nurture world class clinical product development capacity in India.
CDSA
invites applications from high performing professionals with a desire
to serve public health needs of the country for the below mentioned
administrative position.
Recruitment No: CDS/RN/01/2015
Name of the post / Emoluments and Age
FULL TIME CONSULTANT – CLINICAL DATA MANAGEMENT
(up to Rs. 75,000/- per month consolidated)
Age Limit: 45 years
Qualifications and Skills Master’s degree level (biological/ life science, pharmacy or other health related discipline preferred)
Skills
Good oral and written communication skills in English.
Demonstrated ability to work independently and in a multidisciplinary team.
Demonstrated ability to manage and motivate direct reports
Excellent
interpersonal, verbal and written communication skills, (including
experience in making presentations at conferences, meetings, training
sessions)
Able to role model behaviours and ethics in line with CDSA Mission, Vision and Values
IT literate
Knowledge
of SOPs/ Guidelines/ System Life Cycle methodologies, GCP and any other
applicable local regulations and proven practical application.
Tenacity to work in an innovative environment.
Personal
skills include ability to manage competing priorities, function
independently, attention to detail, excellent organizational skills, and
flexibility to change and fulfilling activities to completion.
Demonstrated ability to learn new systems and function in an evolving technical environment.
Experience
8-15 years in clinical data management with at least 5 years of management experience
Sound understanding of the global drug development process
Ability
to develop/advise on training programs for Data Scientists/Technicians
and data management workshops for Clinical Research staff
Ability
to establish strong working relationships with others in the drug
development process, particularly within Clinical Research
Familiarity with SAS programming
Well-versed
in regulatory requirements for validation of data management systems,
GxP, Good Clinical Data Management Practices (GCDMP)
Experience
in various phases of clinical trials with full project life cycle
experience (CRF design to database lock and reporting); use of
commercial and/ or proprietary clinical data management systems, coding
dictionaries/encoding systems (e.g. MedDRA, WHODRL), other software in
support of data management activities (e.g SAS, Access, SQL, Oracle),
programming skills and experience with electronic data capture a
definite plus
Job profile
Take responsibility for managing Data Management.
Provide
technical leadership, resource management and project management for
the required technical aspects supporting clinical trial activities.
Ensure
quality, timeline and productivity requirements are met or exceeded.
Included in this are project planning and implementation, milestone
tracking, organization and participation in team meetings, monitoring
progress and providing updates as required
Create,
direct and maintain strategies in line with the Clinical Operations
and/or Biostatistics organization to help facilitate efficiencies within
the department.
Manage a team local to a
site to provide work direction task prioritization, supervision,
assistance and career development to assigned tasks.
Manage
all phases of data management activities from study start up to
database close and not limited to database set-up, CRF design, data
entry, validation/ edit checks, data transfer, and any ad-hoc
programming required to support a clinical trial process
Lead cross-functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical studies.
Identify and adequately resolve operational and technical problems. Manage process improvements.
Communicate
with the other operational groups regarding workflow, process,
timelines, and resource planning to ensure transparency between the all
functions as well as any external support groups.
Define, develop and deploy appropriate operating procedures.
Work
closely with the Quality Management Groups (QMG) to ensure compliance
with SOPs/ Guidelines, GCP and any other applicable local regulations.
Provide relevant training/mentoring for staff
to assist them in resolution of problems encountered in the conduct of
their daily work or on application of Clinical Systems.
Co-ordinate
the improvement and implementation of tools, including, but not limited
to standard project directories and subdirectories, document file names
and status reports that result in improved efficiencies and quality.
Attend
(as appropriate) client facing meetings to represent the CDM group on
activities including, but not limited to, progress reviews, technical
updates on key milestones, bid defences, technical requirements
collection. Represent the CDM group at internal and external audits and
regulatory inspections, as required.
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be
from a recognized Board/ University and full-time. 2. The experience
requirement specified should 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 age limit,
qualification, experience and other requirements for the posts are
relaxable at the discretion of the competent authority, in case of
candidates who are otherwise suitable. Candidates not found suitable for
the posts notified, can be offered a lower post on the recommendation
of the Selection Committee.5. Number of positions filled will be as per
the Institute’s need and availability of the suitable candidates. 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. The Consultancy fee for the
position of Consultant, Clinical Data Management is a consolidated sum
without any other benefits. Salaries mentioned against the position are
indicative and actual salary will be based on experience,
qualifications, skill set, etc. of the candidates. 8. Incomplete
applications will stand summarily rejected without assigning any
reasons. 9. All results will be published on our website and all future
communications will be only through email. 10. This position will be
placed in CDSA Faridabad office located at NCR Biotech Science Cluster
at Faridabad Gurgaon-Expressway, Faridabad. 11. Please ignore the Demand
Draft (DD) part while filling the online form. 12. Canvassing in any
form will be a disqualification. 13. Interested candidates are requested
to submit the online application on or before the last date and send
the signed hard copy on or before the specified date.
The procedure for online application:
a.
Before filling online application, do keep the following documents
handy: i. A soft copy of your passport size photo. ii. A comprehensive
CV (PDF format only) containing details of qualification, positions
held, professional experience/distinctions etc. b. Candidates are
requested to use Google Chrome internet browser for best results in
submission of online application. In case of difficulty in filling up
the online form, please contact admin@thsti.res.in d. On successful
submission of your application, an auto-generated email containing a
reference number will be sent to the email address provided. Please keep
a note of the reference number for future correspondence. Please do the
following after submission of online application: Take a print out of
the application. Please sign the application at the appropriate place
and send the signed application with CV, selfattested copies of
certificates / documents pertaining to educational qualification and
experience by speed post /registered post so as to reach us on or before
the last date at the address given below. HR Department Clinical
Development Services Agency (CDSA) (An extra mural unit of Translational
Health Science and Technology Institute) NCR Biotech Science Cluster,
3rd Milestone, Faridabad – Gurgaon Expressway, P.O. Box No. 04,
Faridabad – 121001 Please superscribe the post applied for on the
envelope. Please note that application without signature, or those
received after due date or incomplete in any other respect will be
summarily rejected.
Important dates: Last date for submission of online application:30.05.2015
Last date for receiving the signed hard copy of application at CDSA:
30.05.2015 Candidates who have applied for this position in response to
the earlier advertisement need not apply again. Applications will be
accepted up to May 30, 2015.
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