US$140000 - US$141000 per annum
12 months ago
Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews).
This role participates in cross functional team communications and meetings with both internal and external collaborators and oversees the data management activities at contract research organizations (CRO).
The Lead Clinical Data Manager will also participate in the development of department documents and procedures and mentor more junior data management staff.
Functions as internal Data Management Study lead, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports.
Works to ensure on-time achievement of major data management deliverables and milestones in coordination with other functions
Reviews and provides input into protocols and other clinical study documents during development
Reviews and manages key documents such as data management plan, guidelines for CRF completion, data review, SAE reconciliation, and data audits.
Provide DM-level review and input on study medical coding
Following CDISC conventions, oversee or perform eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications; Participate in user acceptance testing (UAT) of the clinical database, including edit check testing
Provide input on Company specifications for internal study team data review plan and guidelines and Protocol Deviation specifications document
Participates in study team data review; Perform data review for quality issues and general data trends; generate queries as necessary
Defines/oversees data transfer specifications for external data sources (labs, ECGs, PK) and transfer of data; reconcile or oversee CRO lab reconciliation with clinical database
Provide input on standard tools and reports
Represent Company Data Management function at study level, and with internal colleagues.
Bachelor's degree in scientific/technical discipline is required
5+ years of relevant work experience with a focus on data management
Knowledge of clinical data management outsourcing with full-service global CROs and niche service providers
Experience in clinical oncology indications, end points, data flow, data integrity, standards and data quality