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GOVT. THSTI-CDSA LIFE SCIENCE JOB @ SALARY 1LAKH /PM

CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,
Department of Biotechnology, Ministry of Science & Technology, Govt. of
India
3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway,
Faridabad – 121001 (Haryana)
RECRUITMENT NOTICE NO: CDS/RN/9/2020

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Name of the post

Program Manager – CPM, CDSA (01 Position)

Emoluments

Up to ₹ 1,00,000/- per month

Duration

(One Year)

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Location

CDSA Office, Faridabad

Age Limit

Upto 45 Years

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Job profile

 To oversee the management of a portfolio of
trials/ studies including project management,
quality monitoring and/or safety monitoring and
guiding the study teams to achieve successful
completion of all assigned activities in the project
 To support the Director CPM and other team leads
in the implementation of systems for resource
planning, study/trial administration and document
management, data management and quality
assurance.
 To contribute to research in design and conduct of
trials/studies.
 Provides Leadership to: Project Manager/ Clinical
Trial Manager, Senior Research Officer/ Research
Officer, Clinical Research Associate/ Study Monitor,
and Project/Clinical Trial Assistant.
 Has direct line management responsibility for upto
5 Project / Clinical Trial Managers
 Works Closely with: Project Team Members, Site
Study team (Project Coordinator, Investigators),
Expert groups/ Committee, Regulatory Affairs,
Medical Affairs & Medical Writing, Data
Management, Biostatistics, Central Laboratory, key
Institute staff on finance, administration, contracts
and personnel matters.
 External relationships: Investigators, Clinical
collaborators, Sponsor counterparts and
management, third party contractors and
regulatory authorities.

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A. RESPONSIBILITIES AS LEADERSHIP AND
STRATEGY:

 Support Director CPM on the development of
systems for overseeing and reporting on clinical
trials / studies and medical device portfolio
 Help develop mechanisms for prioritizing clinical
trials/ studies for sponsorship
 Ensure consistent application of core CDSA policies
and operating procedures across the CDSA
sponsored trials/ studies portfolio
 Act as the lead on behalf of CDSA for projects,
meeting with internal and external partners
(academic and industry collaborations, vendors,
sponsors and manufacturers and regulators)
 Continually review and respond to changes
required to shape the infrastructure, functionality
and standards of clinical trials/ studies
management, including the development and
implementation of systems, operating procedures
and policies.
 Provide expert support to projects with regards to
compliance, policy, sponsorship and high-risk
studies
 Represent CDSA at regulatory inspections and
meetings as required
 Support the Director CPM, collate project reports
and write position papers as well as advising on
“higher risk” studies and in the development of
overall strategy
 Oversee and draft Memorandum’s of
Understanding (MoU’s) or other documents to
outline the delegation of duties from the sponsor
office to CDSA and other stakeholders of the
projects. This will be done with the Administrative
Manager
 Actively contribute to or lead on initiatives related
to the development of CDSA including resourcing,
skills and training, systems and aligned risk
assessments and strategies
 Support Director CPM for escalations and trouble
shooting where issues or concerns are raised by
researchers with regards to trials and “higher” risk
studies
 Ensure the dissemination of information for CDSA
staff on the CDSCO/ ICMR Clinical Trials
Regulation and its implications, regulatory

requirements, research governance and Good
Clinical Practice (GCP).

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B. OPERATIONS MANAGEMENT:
 Oversee a portfolio of studies
 Organize meetings with clients (Investigators/
sponsor) to understand and negotiate the scope of
the contract/ work and any Services Agreement in
place for the client
 Prepare the Scope of Work for a assigned study/
trial
 Oversee preparation of initial budget for the
project and support the finance department in
preparation of budget for carrying out the
assigned Scope of Work
 Review the Scope of Work with appropriate
functional heads to identify staff necessary for the
project team
 Prepare the project management plan, quality
monitoring plan, safety monitoring plan, etc
depending on the scope of work for the assigned
study
 Support overall planning of the study with the
investigator or team leading each project.
Activities include but are not limited to early
involvement in trial planning and budgeting, site
level budgeting, site selection and evaluation, trial
drug forecasting and negotiation with external
providers, trial operational risk assessment,
development of the data monitoring plan and trial
team training.
 Input into study/trial protocols, informed consent
forms, CRFs, and other trial related documentation
 Solicit expert advice, develop collaborative
relationship with key experts and investigators
 Support the client/ investigator in preparing the
dossier for submission to IEC/ regulatory agencies/
HMSC, etc
 Review and support the investigators to finalize
responses to IEC/ regulatory agencies/ HMSC, etc
 Participate in clinical review meetings
(teleconferences live meeting and or face to face)
and document preparation meetings as required
 Provide input as necessary to Feasibility Studies,
Data Safety Monitoring Committee (DSMC) and
other committees, clinical/ product development
planning meetings
 Provide or support project-related training as
needed for team members
 Initiate the project following Best Practices in
Project Management
 Attend and represent project management/
contracted services at internal meetings and
investigator meetings
 Ensure information entered into management
system is accurate, and updated on a regular basis
 Ensure the project is progressing according to
quality standards, SOPs, regulations, and
guidelines
 Use project management plan as a tool to record
and measure progress, updating as necessary
 Track resources and actual time spent on each
project task for all team members to evaluate
project progress
 Determine the cause of project overruns, discuss
with line manager, recommend and institute
corrective action, with input from functional
Primaries
 Follow through on actions required
 Ensure the project is completed within the budget,
schedule, and according to contract specifications
 Line manage project management staff within
portfolio and manage with the Director CPM any
performance management issues which arise with
assigned staff
 Support the study/trial teams in their
development, mentoring new trial and quality
managers.
 Supporting the Director, CPM in preparing or
contributing to the production of any type of
clinical document, for either internal CDSA
customers or external clients, for investigational
drugs, biologicals, or medical devices
 Revise SOPs or suggest process improvements for
consideration.
 Support the Director, CPM in business
development activities.

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C. QUALITY MONITORING:
 Work with investigators/ sponsor prior to start of
project on incorporation of quality management
processes into the scientific and operational design
of the trial
 To offer support to investigators/ sponsor to
ensure compliance with applicable regulations and
policies;
 Oversight of safety data processes within the
portfolio
 Develop a monitoring plan with project
investigators that is tailored to the specific human
subject protection and data integrity risks of the
trial
 Agree predefined quality tolerance limits to identify
systematic issues that can impact subject safety or
reliability of trial results
 Provide advice and support for site feasibility
 Oversight for quality monitoring as per the
approved plans.
 Visit sites and participating institutes as and when
required

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D. COMMUNICATIONS:
 Serve as primary contact from CDSA for the
project
 Communicate to team members the scope of
work, timeline and project goals, technical
information, and input from client throughout the
project
 Inform team members of any new information or
modification of project-related issues which may
affect specific responsibilities of team members
 Work with appropriate Managers (project/ quality)
on any anticipated need for addition or reassignment of resources
 Communicating with study investigators for
evaluation of status of patient recruitment and
progress to study timelines; supporting safety
reporting and IEC submissions; maintaining and
reporting metrics for clinical site performance
 Provide Line Manager with input regarding team
members’ performance as needed for employees’
periodic Performance Review
 Prepare administrative/ monitoring/ safety reports
and submit to clients as required by the contract
exhibit
 Communicate fiscal, contractual, resource,
deliverable and client-related issues to Director
CPM as appropriate

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E. TRAINING:
 Develop project specific and protocol specific
training
 Provide guidance and operational area training for
project team members and staff as required
 Act as mentor for study staff and oversight for
their training and development.
 To develop detailed understanding and provide
guidance to the study team on the implications for
clinical research of specific regulations and
guidance such as the clinical trials regulations,
Data Protection Act, and the regulatory and
logistic aspects of international trials
 Faculty for training programs conducted by CDSA

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F. RESEARCH:
 To coordinate a monthly journal club
 To contribute to reviews/commentaries
 To contribute to original research in design and
conduct of trials/studies including contribution to
study design, funding applications, conduct, data
analysis and drafting of publications

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Qualifications and Experience

Education:
Essential
 Bachelor’s in medical sciences or Master’s
degree/ diploma in life sciences, pharmacy,
public health, healthcare or other related
discipline
 MBBS/ BDS/ BHMS/ BAMS/ BPT preferred or
 Post graduate degree in a health related
discipline
Advantageous
 Postgraduate degree in Public Health
 MD/DNB from a recognized Indian University/
recognized by MCI
 PhD in a health related discipline

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Work Experience:
Essential:
 8 or more years of experience in clinical project
management and/or clinical trial/ study
monitoring
 Experience of clinical trial or public health project
management in a recognized
organization/institute (academic clinical trials
unit, CRO, pharmaceutical, biotechnology, or
device company)
Advantageous:  Demonstrable experience of leading a team  Experience of line management  Demonstrable application of project
management concepts
 Demonstrated ability to understand, explain and
communicate project concepts (project life cycle,
scope planning, scheduling, implementation of
project plan), and manage project conduct
(schedule, quality, and cost control, risk and
change management) using standard tools and
templates
 Excellent interpersonal skills  Experience of managing a complex public health
study/ clinical trial of an IMP
 Highly developed communication skills both
written and verbal
 Significant experience of project management in
industry, major academic clinical trials unit or
epidemiological/public health research setting
 Comprehensive understanding of Indian Clinical
Trials Regulations, ICH and CDSCO Good Clinical
Practice
 Ability to evaluate risks inherent in clinical
studies/ trials and decide those which should be
prioritized to ensure that risks are properly
managed
 Outstanding organizational skills, managing
several projects that are often time pressured,
concurrently. Ability to prioritize activities in spite
of conflicting pressures

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Skills

 Leadership skills that include the ability to build
effective project teams, ability to motivate
others, delegation, drive and timely/quality
decision making
 Personal qualities that include the ability to gain
trust and confidence with a variety of clients,
good learning ability, managerial courage, action
oriented and resilience in a fast
-paced and
rapidly changing environment
 Business/ Operational skills that include
commitment to quality management and
problem solving
 Influencing skills including mhnbvegotiation and
teamwork
 Effective communication skills that include the
provision of timely and accurate information to
stakeholders, proficient in English, strong written
and oral communication skills
 Computer literacy in Word, Excel, PowerPoint,
Access or other trial management systems
 Ability to develop and deliver presentations,
prepare technical reports and contribute
effectively in the manuscripts
 Ability to develop and implement monitoring
plans and SOPs
 Ability to make evaluative judgments, remain
flexible as projects and priorities change
 Demonstrated ability to prioritize workload in
order to meet multiple deadlines
 Ability to work independently with minimal
guidance as well as collaboratively within a team
setting
 Knowledge of regulations and guidelines
pertaining to the conduct of clinical trials/ studies
on human subjects

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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 qualification, experience and and the number of the position and the 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. No TA/DA will be admissible to appear in the interview, including (SC/ST
    candidates).
  6. Only candidates who can join immediately needs to apply, as the
    position is to be filled on an urgent basis.
  7. This position will be purely on temporary positon for a duration of One Year.

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March 2020
M T W T F S S
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Monday
9:00 AM – 5:00 PM
Tuesday
9:00 AM – 5:00 PM
Wednesday
9:00 AM – 5:00 PM
Thursday
9:00 AM – 5:00 PM
Friday
9:00 AM – 5:00 PM
Saturday
9:00 AM – 5:00 PM
Sunday
Closed
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