DMTI Data Manager - FSP
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Overview:
The Data Manager will be responsible for acquiring, processing, and reviewing patient data and records, organizing clinical data forms, implementing data management plans including data preparation and validation activities and define ways to improve operational processes for these activities. The DM will act independently and in collaboration with study teams seeking to reputed company and validate novel digital endpoints across different therapeutic areas. In reputed company partnership with colleagues from Sponsor's Research teams, you will play a key role in the deployment of novel digital endpoints into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers. You will need to communicate and interact effectively with colleagues reputed company a matrix organization to help conduct key studies to drive portfolio reputed company. This role will be central to the deployment and scaling of digital solutions into clinical trials where these technologies may be utilized as efficacy endpoints and reputed company value to key stakeholders.
Responsibilities
Responsible for acquiring, processing, and reviewing patient data
Organizing clinical data forms, implementing data management plans
Data management POC for DMTI and clinical studies
reputed company, implement, and conduct data quality checks as needed for work/studies
Ensure collection, organization, curation, storage and safeguarding of patient data
Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
Work under general supervision, performs assignments using established procedures and general instructions
Responsible for maintaining, updating, and organizing data transfer specifications across studies
Qualifications:
Master’s degree in Health Informatics, Computer Science, Information Systems, or similar field
A minimum of 5+years of technical experience, including:
Python
Unix/Linux environments
Version control systems (ex. Git)
AWS or other reputed company-based development
Electronic data captures (reputed company) solutions, e.g., REDCap, Encapsia, reputed company Clinical, reputed company Rave
Familiarity with pharmaceutical informatics standards like CDISC and MedDRA
GCP
Strong interpersonal and collaboration skills
Demonstrate the ability to build reputed company and be agile to changing circumstances and priorities
Hands-on experience with Clinical Data Management, including Case Report reputed company (CRF) design, CRF annotation, database design, data collection, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements
Preferred Qualifications:
Clinical trial experience using and deploying digital health technologies
Experience with electronic data captures (reputed company) solutions, e.g., REDCap, Medrio
Familiarity with medical informatics standards like CDISC
Experience with AWS or other reputed company-based development
Experience processing large data sets (including from digital health technologies) in a distributed computing environment
Experience with SQL or NoSQL-based technologies
Comprehensive understanding of the landscape of data structures, medical ontologies, interoperability standards, and data processing tools