Clinical Data Manager
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Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
Candidats profile
Education & Experience
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.
Candidats profile
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
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
Key Skills
- SQL
- Data Collection
- GCP
- Master Data Management
- R
- Data Management
- Clinical Trials
- User Acceptance Testing
- Data Warehouse
- SAS
- Oracle
- Data Analysis Skills
