Available Positions

TITLE: SR. CLINICAL DATA MANAGER

DUTIES: Create clinical data management plans (DMP) & maintain DMP though project lifecycle according to study design & requirements; Develop Validation Plans, Risk Assessment, Traceability Matrix complying to 21 CFR Part 11, Gxp, Data Integrity Standards & Audit Trails; Lead development of study specific Data Management Plans, Vendor Management plans, Cross-functional data review plans, eCRF completion guidelines, Data Transfer Specifications, eTMF maps, & CDM documents; Prepare SOPs, Data Management Plan, Coordinate database design, development, implementation, maintenance & user support of clinical systems; perform and manage project close-out tasks including database lock / freeze, unblinding &, access changes; Support Data Managers through subject data reviews, data listings, identifying data discrepancies, verify data query resolutions including resolution of data issues from clinical & statistical groups. Skills: DMP, Audit Trails, eTMF maps & CDM. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. Send Resume to PVR Technologies, Inc, 501 Allendale RD, Ste 201, King of Prussia, PA 19406.

 

REQUIREMENTS:    Master’s degree in Computer Information Systems, Computer Science with 6 months of experience in a job title with similar duties and skills.

 SALARY:                               $106, 226.00/Year

 HOURS:                   40 hours/week, Mon- Fri, 9:00am – 5:00pm

 JOB LOCATION:            PVR Technologies, 501 Allendale RD, Suite 201, King of Prussia, PA 19406

 CONTACT:                           Holly Cox, HR Associate, Phone: 610-337-1935 Ext 1923