About the Role

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 Responsible 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.

📌 Clinical Data Coordinator (India)
🏢 CosMicIT
📍 India