Clinical Data Manager

FLSA Classification: Exempt/Salary 

Schedule: Monday – Friday; 8:00 am – 5:00 pm; possible evening and weekend work 

Department: Clinical Sciences 

Reports to: Associate Director Clinical Sciences 

Supervisory responsibilities: No 

Location: Fully Remote 

Position Summary/objective: 

Ensuring GCP compliance in all data management related topics as well as integrity and 

 quality of all collected and stored data of a clinical trial. 

Essential functions: 

Main responsibilities of this position will include but are not limited to the following tasks:  

• Planning, conduct and closure of clinical trial data management activities within timelines, budget and with high quality 

• Providing functional area input into GCP/GCLP vendor selection and support with vendor qualification from Clinical Data Management point of view following the effective SOPs 

• Performing / overseeing of following clinical data management activities 

• Clinical trial set up phase: data management plan, database (eCRF design specification, edit check specification, data review plan, eCRF completion guidelines, IRT specification, Coding Plan, SAE reconciliation Plan, data transfer specifications, database programming, UAT plans, UAT performance, database GO Live, etc. 

• Clinical trial maintenance phase: data reconciliation, data listings, data review, query management, data cleaning, data transfer, management of laboratory normal ranges, site & user access management, etc. 

• Clinical trial close out phase: Final reconciliation, query closing, patient profiles, database lock. QC (Quality Control) of all filed documents.  

• Performing or overseeing of development, implementation and change management of clinical data management systems (i.e., eCRF & RTSM (Randomization and Trial Supply Management), Imaging, SAS, Review, etc.) 

• Ensuring Clinical Data Management related training of clinical trial team and external vendors  

• Ensure CDISC standards are followed (SDTM/CDASH/ADAM)  

• Participate in the definition and implementation of eCRF / IRT standards  

• Reviewing and input of clinical trial documents (i.e., clinical trial protocols, statistical analysis plan, safety management plan, DSMB (Data and Safety Monitoring Board) Charter, Deviation Plan, Medical Monitoring plan, etc.)  

• Managing and overseeing centralized monitoring 

• Developing and maintaining SOPs, guidance documents, Templates, standards, training material for clinical data management tasks 

• Data management related System Validation 

• Archiving of clinical trial data management related documents as per TMF Ref Model 

Secondary functions: 

• Support in Trial Budget oversight for Data Management Budget, support in Vendor management, DB- Programing, CDISC Compliant 

Competencies: 

• Identifies and fulfills tasks under own responsibility. 

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