Clinical Data Manager
- India
Posted 5 days ago
About the role
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
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
CANDIDATE'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
- 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 fast-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.