Title: Senior Clinical Data Manager
Data Management Quality Lead (DMQL)
Location: Fully Remote
Duration: 12 months, renewable
About the Company:
One of our top Pharmaceutical clients (10 billion USD in revenue) has 20 openings for a Clinical Data Management lead to join an exciting new project. this role is 100% work from home and the 12 month contract is extendable indefinitely.
- To provide DM subject matter expertise to the study team(s) and is responsible for overseeing and managing all DM activities for the study.
- Serves as a core team member of the study team(s) and is accountable for all DM-related communications, specifications, and documentation that includes but not limited to the Data Management Plan (DMP).
- The DMQL is responsible for the overall quality and integrity of the database with respect to "Critical to Quality" (CTQ) data points predefined by Clinical and Biostats prior to the start of a study.
- The DMQL will "project manager" the Data Quality Plan to ensure CTQ data points are of the highest integrity and completeness.
- Number of studies assigned to DMQL will be based on a given therapeutic area, depending on size, complexity and working model.
o Accountable for the execution and overall quality of DM activities and deliverables.
o Acts as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.
o Provide guidance and supervision to Lead Data Managers/DM Team Leads working on the study (CRO or in-house)
o Accountable for "real time" Data Management, ensuring that DM conducts initial reviews within 5 calendar days of a patient's data entering the EDC system, and manages the average query aging to no more than 30 calendar days.
o Accountable for the overall quality and completeness of the Data Management Plan (DMP).
o Responsible for working closely with the Centralized Data Monitoring (CDM) group to ensure quality and integrity of our most important data points.
* Education: Minimum of a BS in life sciences degree and/or equivalent experience
6 Years minimum lead level experience.
Late phase Oncology experience
Sthree US is acting as an Employment Business in relation to this vacancy.