Job Description

EDC Developer - Medidata Rave Programmer Requisition ID 40108 Job Category Information
Technology Locations USA - Princeton, NJ Shift 1 Job Posting We are seeking aSenior Clinical
Applications Programmerfor our Princeton, NJ office! Job Responsibilities:
Technical leadership with responsibility for delivering technical services (EDC) and
management of data streams of vendor data within the scope of assigned projects to
achieve project integrity and the delivery of on-time, quality data
Act as technical liaison with project team members, and Data Managers to drive the
technical aspects of project delivery.
Mentor and aide in staff development, and achievement of competency standards Assist
in development of global technical services competency models
Assist with the development of training programs to ensure staff, project and technical,
achievement of position competencies. Present training programs to the technical staff
regarding study build, Derivations and Procedures.
Participate in the development of global, harmonized SOPs and specific quality work
instruction for technical service group activities
Maintain technical competency through participation in internal and external professional
seminars and participation in professional organizations
Provide support to data management for time and cost estimates and prepare and
present to potential clients on global technical support capabilities.
Complete work according to Covance SOPs, Work Instructions ,and project specific
guidelines in accordance with Good Clinical Practice
Meet with data manager on assigned projects to discuss technical strategies, contractual
obligations and timelines. Escalate resource needs as appropriate.
Provide leadership and consultation in the area of database design and development with
data managers.
Assist management with evaluation of new technologies as assigned.
Prioritize personal workload to meet specified completion dates and perform work without
direction.
Manage active objects within the Business Unit and Global Libraries.
Review and approve requests for addition of objects to the Business Unit and Global
Libraries.
Develop, implement and maintain standards for Unit Library objects and reports.
Develop, implement and maintain standards for Global Library objects and reports.

 Perform all activities related to study build and design for EDC according to work
instructions.
Conduct Quality Control of study design for assigned projects.
Load standard client specific dictionaries in development area
Grant/ Revoke Study Access Review and approve derivation and validations requested
by the project teams. Discuss alternative programming for procedures, if appropriate.
Program standard and custom reports as assigned.
Provide input into assessments of resource requirements on a regular basis. Provide
feedback to management if any action is needed to increase utilization, improve efficiency
or amend the resource levels required on a project.
Ensure creation of study structure, workflow, patient table of contents, insertion of
investigator, site, patient numbers, page and visit information for imaged studies.
Provide expert technical guidance to project teams, external clients, and junior EDC
Design staff.
Prepare and provide internal training on advanced topics as needed in conjunction with
senior management.
Advise management of changes in scope of projects to enable the timely development of
change orders.
Implement processes as they are refined or as new processes are developed and initiate
and participate in the ongoing review of the processes to ensure they are continually
improved.
Prioritize personal workload to meet specified completion dates and perform work with
minimal supervision.
Provide feedback to management on the development potential of staff to assist in staff
development.
Assist with interviewing and selection of potential candidates utilizing the DDI selection
process.
Perform all work with knowledge of regulations pertaining to computerized systems to
projects to ensure compliance.
Perform other duties as assigned. Education/Qualifications
University/college degree (life science, computer science, programming, pharmacy or
related subject preferred), or certification in a related profession from an appropriately
accredited institution (e.g., nursing certification, computer science, medical or laboratory
technology).
Broad knowledge of drug development process.

 Basic knowledge of budgets and relationship to productivity targets.

Thorough knowledge of the Architect module in Medidata Rave and/or Central Designer
tool for Oracle InForm trials to ensure the efficient build and maintenance of EDC trials.
Working knowledge of SAS, SQL, SQL-Plus, PL/SQL and relational databases.
Working knowledge of medical coding dictionaries and their application.
Knowledge of time and cost estimate development and pricing strategies
Working Knowledge of System Validation Life Cycle in relationship to the implementation
new applications.
Fluent in English, both written and verbal. Experience
Minimum ten years of relevant work experience to include data management, database
support and dictionary support activities including 5 years Medidata Rave and/or Central
Designer or equivalent experience.
Demonstrate excellent problem solving skills, a proactive approach and the ability to
make sound decisions.
Demonstrated skill in leading teams, by example and mentoring staff.
Demonstrate excellent problem solving skills, a proactive approach and a willingness to
make decisions on a regular basis and communicate these clearly.
Excellent oral and written communication and presentation skills.
Knowledge of clinical trial process and data management, biometrics, and systems
applications to support operations.
Working knowledge of the relationship and regulatory obligation of the CRO industry with
pharmaceutical / biotechnological companies.
Demonstrated skills in SQL, PL/SQL. SQL-Plus and SAS.
Demonstrated ability to work in a team environment.
Demonstrated ability to handle multiple competing priorities .
Proven managerial and interpersonal skills.
At Covance, you can make a difference by helping to deliver life-saving and life-enhancing
medicines to people around the world. Our commitment to this mission has resulted in
Covances impressive history of company stability and growth. Weve achieved these results
by fostering a work environment that encourages, develops and leverages our teams
capabilities. Covance believes that their best-in-class employees deserve first-class benefits.
Covance offers an outstanding benefits package including medical & dental insurance,
tuition reimbursement, a 401(k) plan with a generous company match, short and long-term
disability, and life insurance, all of which are effective on your first day of employment! At

Covance, we help make the miracles of medicine a reality. We offer opportunities to work on
diverse, challenging projects with bright, interesting colleagues while building a flexible and
rewarding career. EEO Employer Covance is committed to diversity in the workplace and is
an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to
us.

Ali Ahmed

Tata Consultancy Services

Well experienced in End to End process of clinical trial development (Set up to DBL) which includes
interpreting the Protocol, Creation of Specifications, Building the EDC data base, Programming the Edit
Checks,Custom function, Creation of Test cases and UAT plan and review, Coordination with third party
for lab, ECG& safety data, Creation of SDTM annotation and mapping, define.xml, Conduct and data
base locking activities.
Specialties:
1. Medidata A2W certified in RAVE study set up.(edit check, CRF design, CFs)
2. Expert in migration and post production change management.
3. Expert in core-configuration set up, Lab Administrator and Lab set up.
4. Well experience in study closure and DBL activities.
5. Expert in Translation work bench, Batch Uploader, Administration modules.
6. Skilled in Script Utility Manager.
7. Core Developer & expert in GLIB.
8. Experinced in SDTM, listings&reports and TPD
9. Resource & project management, process streamlining.
Cognizant Technology Solutions
Handled multiple studies for TAs like CVG, Onco, RE, Inflamation, Handled Global Library, Post
production Changes, Resource management, CAPA, Gap Identification and trained new joinees in
Medidata Rave programming and Data Management activities, Co-ordination with Third party Vendors.
Part of Study Set up and data base designe for clinical trials for leading pharmaceuticals and Medical
Device organizations
Rave CRF design, Global library, Edit check programming, testing, coordination with internal and external
team, mentoring & training to new team members etc.
Worked for client specific inhouse tools and applications.
eCRF Design, Edit check programing, DB Testing
----------------------------------------------------------------

Amarnath Reddy's Experience

4+ years of experience in Clinical Data Management using Medidata Rave tool with study design and
build (creation for eCRFs, Validations, Amendments/Migrations, Reports, data extracts, Lab data

integration, Third party data integration etc).

Managing team as per the priorities, providing valuable suggestions and mentoring new hires. Handling
study Matrix, team forecast and participating in the study initiation meetings. Meeting management
performance standards, team supervision and performance management activities.
Specialties
ASPire to Win certified study developer in Medidata Rave 5.6.3
Team Lead for Study Setup and Standard Global Libraries
Handling Phase I - III Oncology studies, studies in Japanese language, Lab integration.

9930003581 Manish
Cognizant Technology Solutions
1. Provide expertise help and drive the team for results.
2. Assigning tasks and providing required support for study setup at offshore
3. Coordinating with onshore team for study initiations and requirements.
4. Plan and Track day to day activities of team members and provide a monthly report.
5. Ensuring the overall quality of deliverables from/to the Data management team.
6. Provide training for new membes in RAVE and Life Science.
7. Ensure the team members are tracking the daily activities.
8. Review the training records and conduct internal audits.

eCRF Developer - Accenture Services

1. Developing electronic case report forms for Clinical Data Capture and Management using
Medidata Rave Tool.
2. Write validations, Configure validations, Verify the validations implemented in the EDC
study and setup of eCDM systems and peer review as required.
3. Execute Quality Control and Quality Assurance test scripts on eCDM systems.
4. Performs testing on RAVE-EDC Core Configuration, Standard Edit Checks, Outputs,
Reports and Study Close.
5. Record and track defects uncovered during the execution of development.
6. Communicate issues to QC management for escalation and participate in meetings to
address research options.

----------------------------------

SANTHOSHKUMAR KANDASAMY

ASSISTANT MANAGER at Tata Consultancy Services

Past

Clinical Database Programmer (MEDIDATA RAVE) at PAREXEL International India Pvt

Limited, Hyderabad.

Senior Technical Analyst at AOSTA Software Technologies India Pvt

Limited at Coimbatore - Tamil Nadu
Education

Bharathiar University, Coimbatore, Tamil Nadu

Anna University, Chennail, Tamil Nadu.

Gandhi Matric Higher Secondary School, Namakkal, Tamil Nadu.

Connections
142 connections
Websites

Company Website
Company Website
Company Website

SANTHOSHKUMAR KANDASAMY's Summary

Working as Assistant Manager for the Clinical Database Programming for RAVE - EDC at TCS,
I have around 7 years Clinical Programming (CDM) experience in life science/ Biotechnology
& Pharmaceutical industry. Responsibilities starting from Protocol reading, eCRF design/study
build, Edit Check & Custom Functions programming, Migration and maintenance using
Medidata RAVE 5.6.2, 5.6.3 and 5.6.4.
Desire and deserved to play the Manager/SME role. Expertise to manage and support all
functional and technical activities and on time project deliverable with first time quality from
single clinical trial assignments to large programs of clinical trials. Also I have good
knowledge on ICH-GCP, 21 CFR PART-11, CDISC and Applicable Regulatory Guidelines.
TOOL EXPERIENCE:
Medidata Rave
RaveManage
RaveDirect
Thesaurus Management System (TMS)
MS-SQL Server 2005, 2008
MS-Visual Studio 2005, 2008
INTEGRATION ACTIVITIES:
Rave
Rave
Rave
Rave
Rave
Rave
Rave

SODA integration
CTMS integration
TMS integration
Drug Safety integration
Pregnancy integration
SAS integration
LAB integration

SKILL SET AND SPECIALTIES:

Medidata Trained Study Builder
Custom Function Developer
Core Configuration Set-up
Expertise in Medidata Rave (EDC)
Handling Rave - L2 & L3 support activities

Knowledge on RAVE-Entity Relationship Diagrams (ERD)

ISTQB certified Test Manager (ISTQB-AL-TM)
Team Management experience to Virtual & Direct Teams
Process Migrations/Movements
BUSINESS/CUSTOMER RELATIONSHIP EXPERIENCE:
Closely worked with the customer at client location San Francisco, CA, USA. Currently
working with off-shore team.
SHORT TERM ASPIRATION:
Get certified from Medidata on Train The Trainer (TTT) by or before March-2014.
OBJECTIVE:
Permanent employee with Medidata as a Senior Project Manager, December - 2019.
VISA STATUS:
USA - R B1/B2 Valid till 02-DEC-2022

ASSISTANT MANAGER TCS

1. Manage a team of professional Data Management Programming staffs. Directly
responsible for utilization of staff.
2. Define resource requirements and work with supervisor to prioritize resource
assignments across projects.
3. Implement department/office objectives.
4. Provide review and guidance for production of Data Management documentation or
deliverable(s) that are produced by the Data Management Function (such as database
design and set-up, validation definition and programming, and database deliverables to
internal and external customers).
5. Provide technical advice and solutions with internal and external customers to solve
problems and improve efficiency.
6. Participate in the implementation of new processes and technology. Ensure that staff is
trained and compliant with current operating procedures and work instructions and
project scope of work.
7. Identify and address professional development/training needs of staff. Mentor staff
members to develop Data Management Programming process and system expertise.
8. Serve as primary contact for customer interactions at project level with a focus on
specific Data Management Function.
9. With established customers, provide operational input into proposals and scope of
work. May participate in proposal defenses.
10. May participate in customer meetings and lead discussions of project programming
requirements and strategic planning.
11. Understand scope of work, budget, and scope assumptions. Identify out-of-scope
work and contribute to estimating costs of this work.
12. Ensure project milestones pertaining to Data Management Function are met
according to agreed upon timelines with high quality.
13. May spend significant time performing work tasks associated with Data Management

Programming Function, typically in a lead role.

14. Manage staff in accordance with organizations policies and applicable regulations.

Clinical Database Programmer (MEDIDATA RAVE)

PAREXEL International India Pvt Limited, Hyderabad.
Public Company; 10,001+ employees; PRXL; Pharmaceuticals industry

April 2010 May 2012 (2 years 2 months) Hyderabad

1. Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC
system and Setup Core Configurations
2. Implementing the Dynamic rules as per the Sponsor requirements
3. Experienced in writing the Data Validation Specification (DVS)
4. Create, test and maintain trial specific plausibility and consistency Edit Checks as per Data Validation
Specification
5. Analyze complex checks and Develop Custom Functions using C# for Rave studies
6. Expertise in performing Technical and Functional Review
7. Incorporate internal feedback and update programs as required
8. Incorporate Sponsor Acceptance Testing (SAT) feedback
9. Maintain and update the eCRFs and its components as required for protocol amendments or required
metadata updates
10. Perform second/final review for peer deliverables
11. Creating RAVE System Configuration Specification (Core config, Report Config, e-learning config,
Appendix config & coding spec in RAVE)
12. Incorporate RAVE Configuration Specification
13. Facilitating Internal Configuration Review Meeting (ICRM)
14. Revise and update eCRF booklet, DVS and Configuration Specification
15. Facilitating Sponsor Acceptance Meeting (SAM)
16. Handling issues related to QC/UAT/PROD and track issues to closer
17. A seasoned resource on Double Data Entry (DDE)
18. Expertise in Critical Data Point Strategy (CDPS) or SDV implementation
19. Review of the DVS for clarity and to ensure checks are consistent and appropriate based on eCRF
design. Provide feedback to DVS author.
20. Support CRO trial activities, including CRF annotation, database setup, specification generation,
Clinical view settings and dataset comparison
21. Creating BOXI reports as per the Sponsor specification document
22. Estimate and perform migration process for Post Go-Live studies
23. Performing DB Coordinator role for multiple trials
24. Mentor new hires in CRO and EDC activities
25. Medidata Trained Study Builder

Senior Technical Analyst at AOSTA Software Technologies India Pvt Limited

Coimbatore - Tamil Nadu
July 2006 April 2010 (3 years 10 months) Coimbatore Area, India

As a Clinical Programmer, was responsible for

1. Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC
system and Setup Core Configurations
2. Implementing the Dynamic rules as per the Sponsor requirements
3. Experienced in writing the Data Validation Specification (DVS)
4. Create, test and maintain trial specific plausibility and consistency Edit Checks as per Data Validation
Specification
5. Analyze complex checks and Develop Custom Functions using C# for Rave studies
6. Expertise in performing Technical and Functional Review and Reporting
7. Incorporate internal feedback and update programs as required
8. Incorporate Sponsor Acceptance Testing (SAT) feedback
9. Maintain and update the eCRFs and its components as required for protocol amendments or required
metadata updates
As a Functional Consultant, was responsible for
10. Understanding customer business process.
11. Customer Requirement Specification document analysis.
12. Software Requirement Specification document analysis.
13. Fit gap analysis.
14. Preparation of review meeting, inspection process meeting.
15. Configuration and testing of business process.
16. Trained the users on EDC product.
As a Technical Tester, was responsible for
17. Preparation of test case design and Execution.
18. Testing- unit testing, integration testing and System testing.
19. Defect tracking and reporting.
20. Preparation of Traceability matrix and monitoring.
21. Preparation of test cycle and summary reports.
As a Technical Writer, was responsible for
22. Preparation of business scenarios document
23. Preparation of user manual

----------------------------------------

EDC Developer - Medidata Rave Programmer

Report as suspicious

Listing Info
We are seeking a Senior Clinical Applications Programmer for our Princeton, NJ office
or remote based!

Job Responsibilities

Technical leadership with responsibility for delivering technical services (EDC) and
management of data streams of vendor data within the scope of assigned projects to
achieve project integrity and the delivery of on-time, quality data
Act as technical liaison with project team members, and Data Managers to drive the
technical aspects of project delivery.
Mentor and aide in staf development, and achievement of competency standards
Assist in development of global technical services competency models
Assist with the development of training programs to ensure staf, project and technical,
achievement of position competencies. Present training programs to the technical staf
regarding study build, Derivations and Procedures.
Participate in the development of global, harmonized SOPs and specifc quality work
instruction for technical service group activities
Maintain technical competency through participation in internal and external professional
seminars and participation in professional organizations
Provide support to data management for time and cost estimates and prepare and
present to potential clients on global technical support capabilities.
Complete work according to Covance SOPs, Work Instructions ,and project specifc
guidelines in accordance with Good Clinical Practice
Meet with data manager on assigned projects to discuss technical strategies, contractual
obligations and timelines. Escalate resource needs as appropriate.
Provide leadership and consultation in the area of database design and development
with data managers.
Assist management with evaluation of new technologies as assigned.

 Prioritize personal workload to meet specifed completion dates and perform work
without direction.
Manage active objects within the Business Unit and Global Libraries.
Review and approve requests for addition of objects to the Business Unit and Global
Libraries.
Develop, implement and maintain standards for Unit Library objects and reports.
Develop, implement and maintain standards for Global Library objects and reports.
Perform all activities related to study build and design for EDC according to work
instructions.
Conduct Quality Control of study design for assigned projects.
Load standard client specifc dictionaries in development area
Grant/ Revoke Study Access
Review and approve derivation and validations requested by the project teams. Discuss
alternative programming for procedures, if appropriate.
Program standard and custom reports as assigned.
Provide input into assessments of resource requirements on a regular basis. Provide
feedback to management if any action is needed to increase utilization, improve efficiency
or amend the resource levels required on a project.
Ensure creation of study structure, workfow, patient table of contents, insertion of
investigator, site, patient numbers, page and visit information for imaged studies.
Provide expert technical guidance to project teams, external clients, and junior EDC
Design staf.
Prepare and provide internal training on advanced topics as needed in conjunction with
senior management.
Advise management of changes in scope of projects to enable the timely development
of change orders.
Implement processes as they are refned or as new processes are developed and initiate
and participate in the ongoing review of the processes to ensure they are continually
improved.

 Prioritize personal workload to meet specifed completion dates and perform work with
minimal supervision.
Provide feedback to management on the development potential of staf to assist in staf
development.
Assist with interviewing and selection of potential candidates utilizing the DDI selection
process.
Perform all work with knowledge of regulations pertaining to computerized systems to
projects to ensure compliance.
Perform other duties as assigned.
University/college degree (life science, computer science, programming, pharmacy or
related subject preferred), or certifcation in a related profession from an appropriately
accredited institution (e.g., nursing certifcation, computer science, medical or laboratory
technology).
Broad knowledge of drug development process.
Basic knowledge of budgets and relationship to productivity targets.
Thorough knowledge of the Architect module in Medidata Rave and/or Central Designer
tool for Oracle InForm trials to ensure the efficient build and maintenance of EDC trials.
Working knowledge of SAS, SQL, SQL-Plus, PL/SQL and relational databases.
Working knowledge of medical coding dictionaries and their application.
Knowledge of time and cost estimate development and pricing strategies.
Working Knowledge of System Validation Life Cycle in relationship to the implementation
new applications.
Fluent in English, both written and verbal