PHARMAFull-time
Senior Clinical Database Programmer
By Admin · Clinical Data Management
BANGALORE (IN)REMOTEPOSTED: 8/28/2026
PHARMAFull-time
HIRING ORGANIZATIONPAREXELBiosciences / Healthcare, Contract Research Organization (CRO)
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Lead and supervise the design, implementation and maintenance of electronic data capture (EDC) systems and clinical database management systems (CDMS), using standard or CDISC-compliant formats.
Ensure clinical database deliverables meet regulatory requirements and first-time-quality expectations.
Create, implement and maintain consistency checks and edit checks in standard or CDISC formats.
Apply internal SOPs and external regulatory requirements, including 21 CFR Part 11 and ICH-GCP, throughout database programming activities.
Provide technical leadership and mentorship to programming teams and project staff, including training on eCRF design, database procedures and clinical data-management best practices.
Act as the primary technical contact and liaison for sponsors, data-management leaders and cross-functional teams regarding database-programming issues, technical solutions and project timelines.
Manage database lock and unlock procedures and approve database changes in accordance with SOPs, service-level agreements and regulatory requirements.
Maintain comprehensive technical and regulatory documentation, including deviation logs and traceability records, supporting compliance and audit readiness.
Support integration and programming of systems within Global Data Operations, including CTMS, safety systems and coding systems, while working across multiple programming languages and processes.
Develop, improve and implement project-specific tools and standards to increase efficiency and optimise clinical-trial processes across multiple concurrent projects.
Participate in business-development activities, including bid-defense meetings and technical support for new business opportunities.
Technical & Regulatory Standards
Apply clinical database programming expertise to protect data integrity, accuracy, system optimisation, patient safety and research quality.
Follow SDLC methodologies, SOPs, work instructions, ICH-GCP and applicable regulatory requirements.
Support regulatory-compliant EDC/CDMS design and implementation across clinical-study lifecycles from planning through closeout.
Perform root-cause analysis and make sound technical decisions in ambiguous or complex situations.
Leadership & Stakeholder Impact
Provide strategic technical leadership across database programming activities.
Mentor and motivate virtual programming teams operating across multiple time zones and cultures.
Translate complex technical concepts into clear communication for sponsors, regulatory stakeholders and internal teams.
Collaborate with sponsors, data-management leaders, clinical operations and other cross-functional groups to maintain study timelines and quality.
Qualifications & Experience
Requires 6-7 years of experience in clinical data programming.
Requires proficiency in at least one programming environment such as SAS, CDMS, EDC, SQL, VB or Java.
Requires strong knowledge of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP and regulatory requirements including 21 CFR Part 11.
Requires demonstrated experience in the clinical research industry or a similar regulated environment.
Requires strong communication, organisational and problem-solving skills, with the ability to work independently and collaboratively.
Preferred Qualifications
Bachelor's degree in a relevant science discipline or equivalent work experience.
Certification in at least one clinical systems platform such as Inform, RAVE, DataLabs, Medrio or Veeva.
Experience with multiple clinical-trial systems such as CTMS, medical safety-reporting systems or additional EDC platforms.
Presentation skills and experience supporting business-development activities.
Assignment & Work Model
The role is offered as a 6-month contractual assignment.
Remote locations listed are Hyderabad, Bengaluru and Mumbai, India.
The role involves collaboration with diverse teams across time zones and cultures.
Business & Patient Impact
The position supports the integrity, accuracy and compliance of clinical-trial data and systems.
High-quality EDC/CDMS programming contributes to patient safety, research quality, regulatory readiness and reliable clinical-study outcomes.
The role contributes to Parexel's broader mission of accelerating clinical development and helping bring new therapies to patients.
REQUIRED VERIFIED SKILLS
Clinical Database Programming
EDC
CDMS
SAS
SQL
VB
Java
CDISC
Consistency Checks
Edit Checks
eCRF Design
Database Design
Database Maintenance
Database Lock
Database Unlock
Clinical Data Management
SDLC
SOPs
ICH-GCP
21 CFR Part 11
Regulatory Compliance
Technical Documentation
Deviation Logs
Traceability Records
CTMS
Safety Systems
Coding Systems
Root Cause Analysis
Clinical Research
Quality Management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Parexel is a leading global clinical research organization (CRO) that provides comprehensive biopharmaceutical services. They partner with pharmaceutical, biotechnology, and medical device companies to accelerate the development and market access of innovative therapies. Their services span the entire drug development lifecycle, from early-phase clinical research to regulatory consulting and commercialization.
TEAM SIZE: 20,000+ employees
INDUSTRY: Biosciences / Healthcare, Contract Research Organization (CRO)
RECOMMENDED TRAINING
1/5
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