Data Manager

This position is part of the Medical Affairs team and reports to the Senior Clinical Trial Manager. Responsible for managing the conduct of clinical trials and associated activities related to PGxHealth’s Phase III investigational product in development for the treatment of depression and clinical trials for the development of pharmacogenetic tests:Development of Case Report Forms, Edit Check Specification, Completion Guidelines and Data Handling Plan for paper or electronic studies. Perform Quality Reviews of the RDC system using Oracle Clinical (or any CDMS), SAS, IR and Discoverer.    Create Ad Hoc listings/reports using SAS and other tools as appropriateFamiliarity with Microsoft OfficeReview and approve Data Management Plans prepared by CROs Receive and review all deliverables and ensure the CRO is meeting all deadlines Act as point of contact for the CRO on all Data Management  issues Complete CRF reviews and audits of CRO documentation Attends weekly meetings with CRO and internal study team members Assist with data management for NDA filings

 

Education Bachelor's degree or equivalent; and at least 2 years related experience and/or training; or equivalent combination of education and experience.

 

 

Experience Successful candidate must have experience in clinical study management. 

 

 

Knowledge, Skills and AbilitiesSolid understanding of Phase I, II, and III studies from study start to database lock for RDC and Paper studies 

 Excellent organizational management with leadership experience in dealing with CROs is essential.

 Comfortable working with SAS, Oracle and other DM software. 

 Other skills/abilities include involvement in NDA submissions, ability to understand programming language (SQL, SAS), Medical coding, SAE reconciliation, multi-tasking, problem solving and effective verbal/written skills.