Clinical Project Manager Position Available In Bergen, New Jersey

Manage the progress of assigned studies by tracking regulatory / IRB submissions and approvals, recruitment, and enrollment, CRF completion and submission, and data query generationand resolution; Participate in planning and direction of clinical research studies supporting development of therapeutics for treatment of disease;

Schedule, Plan, and Conduct Site Visits:

Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-out Visits. Manages the progress of assigned studies by tracking regulatory/ IRB submissions andapprovals,recruitment, and enrolment, CRF completion and submission, and data query generation and resolution. Performinvestigational product inventory, ensuring return of unusedinvestigational product to designated location or verifiesdestruction as required. Write Reports and Investigator Follow-up Letters for

Site Visits:

Site Selection Visits, Site Initiation Visits,Interim Monitoring Visits, and Site Close-out Visits. Conduct research to develop methodologies and procedures for data analysis and presentation of clinical research findings; Creates andexecutes project work plans and revises as appropriate to meet changing needs and requirements. Provide leadership to team, setting team KRAs, completing task allocation andcompletion sheet, determine resource needs, identify and justify. Develop project-specific Clinical data management plans that address areas such as data coding, reporting, or transfer,database locks, and work flow processes. Prepare/ Review project specific documents viz. Data Management Plan (DMP), Annotated CRF, Metadata, Data validation Plan/ Edit CheckSpecifications, Self-Evident Correction Conventions (Global Ruling), Data Entry Guidelines (DEG), Data Management Report (DMR), Database Lock/ Freeze forms for both paper-based/RDC studies. Working knowledge and understanding of SAS/Base, SAS/Macros, SAS/STAT, CRF’s, 21CFRPart11, Oracle Clinical, INFORM, CDISC-SDTM, ADaM, Define.xml, MedDRAand WHODD Dictionaries is also desirable.•Science in Pharmaceutical Sciences, Biotechnology, Clinical Research, Microbiology or any other related field of study. Any suitable combinations of education, training or experience areacceptable.