Job Description

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 elluminateanalytics 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.

- CANDIDATES PROFILE.
- Education & Experience.
- 5+ yearsexperience in Clinical Data Management preferred.
- Bachelors 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.
- Strong 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.
- Accelerate your skills and career within a rapid-growing company while impacting the future of healthcare.
- We have shared our story, now we look forward to learning yours!.
- eClinical Solutions is a people first organization.
- Our inclusive culture values the contribution that diversity brings to our business.
- We celebrate individual experiences that connect us and that inspire innovation in our community.
- Our team seeks out opportunities to learn, grow and continuously improve.
- Bring your authentic self, you are welcome here!.
- We are proud to be an equal opportunity employer that values diversity.
- Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

📌 Clinical Data Manager (Bengaluru)
🏢 eClinical Solutions
📍 Bengaluru