From eClinical Solutions's posting. “We” and “our” refer to the employer.
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.
About this listing
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
