Contractor

6 days ago

Noida Uttar Pradesh, India BirlaSoft Full time

Country/Region: IN
- Requisition ID: 30451
- Work Model:

- Position Type:

- Salary Range:

- Location: INDIA - NOIDA- BIRLASOFT OFFICE

**Title**:Contractor**:

- Description:

**Area(s) of responsibility**:
Job Title: Senior Medidata Consultant / Developer (EDC & Coder)
No. of Positions - 1
Preferred Primary Location: Offshore - India Pune, Noida, Bengaluru, Chennai, Hyderabad
Experience Level: 6-10 years
Employment Type: Full-Time

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.
- Key Responsibilities
- Lead the design, development, and implementation of enhancements, custom configurations, and integrations within Medidata platforms.
- 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.
- 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.
- Preferred Qualifications
- Experience in pharmaceutical or CRO environments managing global trials.
- Knowledge of Medidata Rave Architect, Rave Web Services (RWS), and integration with downstream systems.
- Exposure to automation tools and data analytics platforms such as Tableau or Spotfire.
- Understanding of SDTM, ADaM, or other clinical data standards.

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