Contract Clincal Data Manager - Urgent

Duties and Responsibilities: Represents SSI Operations as the primary compound lead for study start-up and data analysis activities within a program or group of programs Acts in a project manager capacity for deliverables supporting the reporting requirements under the Investigational New Drug (IND) application (e.g. IND, Annual Report, Clinical Study Report, and NDA) Represents SSI Operations on assigned Clinical Trial Working Groups (CTWGs) for study start up and data analysis activities Ensures appropriate communication or escalation of study specific challenges and/or change requests proposed by the CTWG to the Standards Governance Lead Ensure CRO and CTWG adherence to clinical data standards and/or escalates to the Standards Governance Committee as required Participates in the development of Standard Operating Procedures (SOPs) and Work Practices (WPs) relating to SSI Operations Responsible for vendor oversight for SSI related activities Experience: BS/RN/RPH degree in health related field preferred, 5+years or MS degree with 3+years experience in Clinical Data Management (CDM) and/or clinical programming in the pharmaceutical/biotechnology industry; knowledge of Good Clinical Practice (GCP), regulatory and International Conference on Harmonization (ICH) guidelines as applicable Clinical experience in the oncology field preferred Electronic Data Capture (EDC) experience desirable or strong knowledge of SOPs, GCP standards and CDM systems

(Real Staffing Group acts as an Employment Agency and an Employment Business)