Clinical Data Specialist

Position Overview
We are seeking an experienced Clinical Data Specialist II to join our clinical research team in Chennai. The successful candidate will be responsible for accurate and timely data entry into Electronic Data Capture (EDC) systems from various e-source documents, including real-time data and Clinical Research Information Officer (CRIO) sources.

Key Responsibilities

Data Management

Perform accurate data entry into EDC systems from e-source documents (Real-time & CRIO).
Conduct data verification and validation to ensure data integrity.
Execute data reconciliation activities between different data sources & EDC.
Maintain detailed logs of data entry activities and progress tracking.

Clinical Protocol & Documentation
Review and interpret clinical study protocols to understand data collection requirements.
Ensure compliance with protocol specifications during data entry.
Maintain thorough understanding of case report forms (CRFs) and CRF completion guidelines (eCCG).
Support protocol amendments and updates as required.

Query Management
Respond to data queries in a timely and accurate manner.
Raise queries for missing, inconsistent, or unclear data points in CTMS/emails.
Collaborate with clinical sites and monitors to resolve data discrepancies.
Close queries CTMS upon satisfactory resolution & respond back to queries in EDC within sponsor required timelines.

Quality Assurance
Conduct thorough quality checks on entered data with zero-defect expectations.
Participate in data review meetings, SIVs, PSVs & Study Kick-off meetings.
Ensure adherence to Good Clinical Practice (GCP) guidelines.
Support regulatory inspections and audits.
Maintain 100% data accuracy standards across all deliverables while meeting strict project timelines without compromising data quality.

Third-Party Data Review
Review and validate data received from third-party vendors (Lab, PK, PD, PRO & eCOA)
Cross-reference third-party data with study databases.
Identify and resolve discrepancies in external data sources.
Coordinate with immediate supervisor for data clarification and correction.

Required Qualifications

Experience
4-5 years of experience in CRC/CRA/Clinical Data Specialist or related field.
Proven experience with CTMS systems (preferably Real time, CRIO, Veeva Vault or similar platforms).
Proven experience with EDC systems (preferably Zelta, Medrio, Medidata Rave, Oracle InForm, or similar platforms).
Experience in pharmaceutical, SMO, or CRO environment.

Technical Skills
Proficiency in Microsoft Word & Excel (Ex: Pivot tables, VLOOKUP, data analysis functions).
Knowledge of regulatory guidelines (ICH-GCP, FDA, EMA).

Core Competencies
Analytical Thinking: Ability to identify patterns, discrepancies, and data inconsistencies.
Clinical Protocol Reading: Strong comprehension of complex clinical protocols and procedures.
Data Entry & Reconciliation: High accuracy in data transcription and validation.
Attention to Detail: Meticulous approach to data review and quality control.
Problem-Solving: Effective resolution of data-related issues and queries.
Quality Excellence: 100% accuracy expected in all data entry activities with zero tolerance for errors.
Time Management: Ability to deliver timely data entry while maintaining quality standards.
Pressure Management: Proven ability to work effectively in high-pressure, deadline-driven environments.
Cross-Functional Experience: Demonstrated ability to work with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and medical affairs.

Communication Skills
Excellent verbal communication skills with strong documentation and reporting capabilities.
Ability to interact professionally with clinical sites, sponsors, and team members.
Team player with collaborative mindset and ability to support colleagues.

Educational Background
Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field.
Experience as CRC/CRA in SMO/CRO organizations (Preferred).
EDC & CTMS certifications (Preferred).