Company: Pharmaceutical Company
Title: Data Management Manager II
Contract Position: 1 year contract term with potential contract extension
Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards. This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third party vendors. Leadership, Direction, and Strategy: • Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies with less complexity. • Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies with less complexity. Project Management: • Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting). • Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. • Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.
Data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO). 5+ years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO) Candidate needs to have strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. Candidate possesses a working knowledge of clinical operations and relevant regulatory requirements. Candidate has moderate skills in continuous improvement, project management, change management, and risk management
MS/BS/RN in life sciences or related field (or equivalent experience
TechData Service Company LLC
Basking Ridge, NJ