Clinical Data Coordinator

CosMicIT; India; On-site; INR 900,000 - 1,400,000; Full time

Job summary

CosMicIT in India seeks a Senior Clinical Data Coordinator to lead data quality, integrity, and regulatory compliance across study startup to database lock.

You will manage data validation, lead database testing (UAT), oversee cross-site query resolution, and mentor junior data coordinators. A CRO/PHarma background and ICH-GCP/CDISC knowledge are required.

Qualifications

• Experience in clinical data management within CRO/pharma/biotech.
• Knowledge of ICH-GCP and CDISC SDTM/CDASH.
• Familiarity with medical coding dictionaries (MedDRA/WHODrug).

Responsibilities

• Lead data review and validation activities for complex trials.
• Review protocols, design eCRFs, and lead UAT for EDC systems.
• Perform data reconciliation across external vendors and sites.
• Be the primary contact for CRAs and sites to resolve data issues.
• Mentor junior team members and contribute to SOPs and DMP.

Skills

EDC platforms

Regulatory knowledge

Project leadership

Education

Bachelor’s or Master’s in Life Sciences/Pharma

Tools

Medidata Rave

Oracle Clinical

Veeva Vault

SAS/SQL queries

Job description

Job Title: Senior Clinical Data CoordinatorJob SummaryThe Senior Clinical Data Coordinator takes a lead role in ensuring the quality, integrity, and regulatory compliance of clinical trial data from study startup to database lock. This role involves managing complex data validation processes, leading database testing (UAT), overseeing query resolution across multiple global sites, and mentoring junior data coordinators.

Responsibilities

• Study Oversight & Data Cleaning: Lead data review and validation activities for complex or multi-center clinical trials, ensuring high-quality, submission-ready data.
• Database Setup & UAT: Participate actively in study startup activities, including reviewing protocols, designing Electronic Case Report Forms (eCRFs), and leading User Acceptance Testing (UAT) for Electronic Data Capture (EDC) systems.
• Advanced Reconciliation: Perform complex data reconciliation across external vendors (e.g., central labs, ECG, imaging, and Serious Adverse Event [SAE] logs).
• Site & Query Management: Act as the primary point of contact for clinical sites and Clinical Research Associates (CRAs) to resolve complex data issues and expedite query resolution.
• Mentorship & Process Improvement: Provide guidance and training to junior team members, assist in writing Standard Operating Procedures (SOPs), and contribute to study-level data management plans (DMP).

Qualifications

• Experience: 4–7 years of direct clinical data management experience within a CRO, pharmaceutical, or biotechnology environment.
• Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Healthcare Informatics, or a related field.

Required Skills

• Technical Expertise: Advanced proficiency in industry-standard EDC platforms (e.g., Medidata Rave, Oracle Clinical, Veeva Vault) and familiarity with data visualization tools or basic SAS/SQL queries.
• Regulatory & Coding Knowledge: Deep understanding of ICH‑GCP guidelines, CDISC standards (SDTM/CDASH), and expert familiarity with medical coding dictionaries (MedDRA and WHODrug).
• Core Competencies: Proven project management skills, exceptional analytical abilities, and the leadership capacity to drive trial timelines toward successful database locks.