Job Description

Experience- 6-10 years

Location- Pune, Noida, Bengaluru, Chennai, Hyderabad

Position Overview

We are seeking a

Senior Medidata Consultant / Developer

with extensive experience in

Medidata EDC (Rave)

and

Medidata Coder

platforms to support, enhance, and optimize clinical trial data management systems.

The ideal candidate will possess a strong understanding of

clinical data workflows

, along with solid

technical troubleshooting

,

configuration

, and

integration

expertise. This role involves close collaboration with global clinical operations, data management, and IT teams to ensure seamless system performance and data quality throughout the clinical lifecycle.

Key Responsibilities

Serve as a

subject matter expert (SME)

for

Medidata EDC

and

Medidata Coder

, overseeing configuration, deployment, and maintenance across multiple clinical studies. Lead the

design, development, and implementation

of enhancements, custom configurations, and integrations within Medidata platforms. Conduct

advanced troubleshooting and root cause analysis

for complex application and data-related issues, ensuring minimal disruption to business operations. Support

system integrations

with downstream and upstream applications (e.g., CTMS, RIM, Safety, and BI tools). Collaborate with

clinical data management teams

to optimize data capture, coding accuracy, and study setup within EDC. Partner with

Medidata vendor teams

and internal IT to manage releases, patches, and validation activities. Develop and maintain

technical documentation

, SOPs, and configuration guides in line with regulatory and compliance requirements. Provide

guidance and mentorship

to junior team members and participate in cross-functional knowledge sharing. Ensure all solutions comply with

GxP

,

21 CFR Part 11

, and corporate validation policies. Actively contribute to

continuous improvement

initiatives, automation opportunities, and process efficiency enhancements.

Required Skills & Qualifications

Bachelor's or Master's degree in

Computer Science, Life Sciences, Information Systems, or related discipline

.

6-10 years

of experience in

Clinical Development IT

, with at least

4+ years

of hands-on experience in

Medidata EDC (Rave)

and

Medidata Coder

. Proven expertise in

system configuration

,

data model understanding

, and

clinical trial setup

within Medidata platforms. Strong

troubleshooting and analytical skills

, with the ability to diagnose complex issues across application, data, and integration layers. Good understanding of

clinical data management workflows

,

medical coding standards

(MedDRA, WHO Drug), and

CDISC/CDASH

concepts. Experience with

API integrations

,

SQL

, and

scripting (Python or SAS)

for automation or data validation preferred. Familiarity with

ticketing and documentation systems

such as

ServiceNow

,

Jira

, and

Confluence

. Excellent

communication and stakeholder management skills

, with the ability to interact effectively with business, IT, and vendor teams. Strong documentation discipline, adhering to

validation

and

compliance

processes.
Job Type: Full-time

Pay: From ?1,500,000.00 per year

Application Question(s):

What is your total years of experience? What is your relevant experience in Medidata EDC (Rave) and Medidata Coder? What is your current CTC? What is your expected CTC? What is your notice period/ LWD? What is your current and preferred location? Are you ok with the third-party payroll? * Have you applied or attended the interview in Birlasoft?