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| MGL is a CMMI level 5 ,PCMM level 3 certified
Organization with 4000 experts working across the globe. It is one of
the most admired companies in specific verticals that we are working
on.MGL offers services across four continents. We provide software
implementation and consulting services throughout the United States,
Canada, Latin America, Europe, India and Asia Pacific.In India, we have
our presence in Delhi, Hyderabad, Chennai, Gurgaon and Bangalore.Our
services are focused to specific verticals like health care and life
sciences, Manufacturing, Media, Publishing and Education, BFSI and
Telecom.We also develop products in our focused areas to provide
solution and enhance our customer�s needs.Our solutions are in
Application Management Outsourcing, Enterprise solutions, Infrastructure
Management, Identity Management and R & D. |
| Designation |
Development Lead |
| Job Description |
Provide leadership to a
cross-funtional software development team that develops and launches
products in the clinical research and clinical care domains
Lead technical activities such as design and development � apply
best-practices in the industry to develop software in compliance with
CMMI requirements
Take a leadership role in adoption and application of Healthcare and
clinical research interoperability standards published by CDISC. ANSI
and HL7
Apply background and expertise in these standards to develop internal
and external-facing specifications for connectivity with MGL-developed
application frameworks
Development of CDISC SDTM mapping specifications
Provide primary support for study standardization to the CDISC SDTM by
creating the SDTM design specifications, including the data definition
files , Annotated CRF and the specification documents
Data Integration and Standardization tasks as converting legacy data
(variety of formats) to SDTM compliant SAS datasets, recoding, SAE
reconciliation, creation of pooled datasets to support ISS and ISE.
Manage the SDTM design specification lifecycle
Oversee execution of the specification by the implementation team
Database design, creation & setup , manage database audit and lock
activities
Train junior staff members
|
| Desired Profile |
Knowledge of CDISC standards of data
storage, transport & regulatory submission - strong working knowledge
and hands on experience of CDASH, CDISC SDTM, ADaM, ODM and CDISC/HL7
standards
Working both autonomously and with the team on educating the team on
CDISC industry standards
Biostatistical Analysis experience
Constantly updated domain knowledge and awareness of future trends �
adapting to changing requirements of the industry in related fields �
CTMS, AERS, ePRO, pharmacovigilance etc
Knowledge of FDA/ICH guidelines
Worked closely in the development of software for CTMS, AERS, ePRO,
pharmacovigilance and EDC |
| Experience |
3 - 7 Years |
| Industry Type |
IT-Software/ Software Services |
| Functional Area |
Application Programming, Maintenance |
| Education |
UG - Any Graduate - Any
Specialization,Graduation Not Required
PG - Any PG Course - Any Specialization,Post Graduation Not Required
|
| Location |
Gurgaon |
| Keywords |
CDASH, CDISC , EDC , ODM, LAB |
| Contact |
Rachna Khanna
Mascon Global Ltd
#59/2, 100 ft ring rd
BSK 2nd Stage
Bangalore,Karnataka,INDIA 560070 |
| Telephone |
91-124450200 |
| Website |
http://www.mgl.com |
| Reference |
DEV_LEAD_12_08 |
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