Clincial Data Manager

Eclinical Solutions; Bengaluru; Hybrid; INR 800,000 - 1,400,000; Full time

Job summary

Eclinical Solutions in Bengaluru, India seeks a Clinical Data Manager (CDM) to lead data management for clinical trials. You will oversee database build, data cleaning, and data reconciliation while ensuring accuracy and timely delivery of study data.

The role requires strong project management, analytics, and collaboration with cross-functional teams, along with familiarity with ICH/GCP and EDC systems. CCDM certification is preferred; bachelor's in a health-related field is required.

Qualifications

• 5+ years experience in Clinical Data Management.
• Bachelor's degree in health-related field or equivalent.
• CCDM Certification preferred.
• Knowledge of ICH/GCP guidelines and 21 CFR Part 11.
• Experience with EDC and Clinical Data Management Systems.

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 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 AI/ML for anomaly and outlier detection to enhance data quality.
• Monitor and interpret KPIs, CTOA, dashboards and reports to provide actionable recommendations to study leads.
• Perform Query Management
• Define specifications and collaborate with technical team on configuration of centralized data management platform (elluminate Data Central) for data cleaning and oversight.
• Prepare and maintain data management documentation (DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
• Review and ensure quality control of team deliverables including eCRFs, study documents, and analytics modules; improve processes for efficiency.
• Collaborate to ensure timely delivery with high quality.
• Ensure compliance with industry standards, regulations, and procedures.
• Other duties as assigned.

Skills

Project management

Analytical thinking

Attention to detail

Collaboration

English proficiency

Education

Bachelor's degree in health-related field

CCDM Certification

Tools

MS Project

MS Excel

ICH/GCP knowledge

EDC systems

Cloud SaaS platforms

Qlik

JReview

Spotfire

CDISC

Job description

OVERVIEW

The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.

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.

Education & Experience

• 5+ years experience 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