Key tasks &

Responsibilities

- Define project specifications for Data Management services, including Protocol Conversion,

Database Build, CRF Design and Data Review and Data Reconciliation tools.

- Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
- Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
- Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.
- Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.
- Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial

Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.

- Perform Query Management
- Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.
- Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
- Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs,



and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.
- Collaborate and work as a team to ensure the deliverables are completed on time with high quality.
- Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures.
- Other duties as assigned.

Candidat's profile

Education & Experience

- 5+ years' experience in Clinical Data Management preferred.
- Bachelor's degree in a health-related field or equivalent experience preferred.
- CCDM Certification preferred.

Professional Skills

- Strong project management experience and project team leadership skills including work planning,

work delegation and solving complex problems.

- Robust analytical and strategic thinking skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills.
- Excellent collaborative skills
- Demonstrated command of the English language with proficiency in both verbal and written communication

Technical Skills

- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
- Proficient with EDC and Clinical Data Management Systems
- Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik,

JReview, Spotfire preferred.

- Experience with RBQM methodology preferred.
- Exposure to CDISC guidelines and standards

📌 Clinical Data Manager (Bengaluru)
🏢 Trigent Software
📍 Bengaluru