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Title:Project Data Manager
Salary:Open
Experience:6
Location:NJ - Eddison

Description:
Responsible for the global planning, organization, and coordination of data management activities in a project; ensures overall database consistency across all studies within a project; manages all activities centered around CRF design, data collection, data retrieval, global integrated database development, coding, and query management for PoC to Phase 4 clinical trials; oversees, monitors, and evaluates all interactions with external vendors (CROs); and ensures data management standards and quality are maintained and implemented.

Responsibilities:
  • Oversees all project related Data Management activities including but not limited to, CRF design, data collection, edit checks, consistency of data collected across investigative sites, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits of the database against data collection instrument sources, database locks, and archival of Data Management deliverables and documents.
  • Primary contact for all project teams, domestic and global, to ensure data quality and timely database delivery.
  • Reviews Data Management performance against established metrics in a Data Management Performance Report, prepared at the conclusion of each study.
  • Ensures that a complete archive of Data Management documents and records is maintained at the site in accordance with applicable regulatory guidelines.
  • Evaluates contracted regional CROs on an ongoing basis to determine if they fulfill requirements of SOPs (including Working Policies (WPs)), timeliness, and quality.
  • Evaluates candidate CROs and external vendors as to their ability to adhere to SOPs (including WPs), and quality standards before any outsourcing contract is finalized.
  • Manages database and supporting documentation archival to meet long-term regulatory requirements.
  • Demonstrates  core competencies at the management level
  • Ensures that all project related outsourcing agreements are comprehensive and complete.

Requirements:
  • MS; BS/RN in life sciences 4 to 6 years (MS) pharmaceutical/data management OR
    6 to 8 years (BS/RN) pharmaceutical/data management
  • Project management experience preferred
  • Good oral and written communication skills.
  • Proficient in Microsoft Office Suite including Word, Excel, and Project.
  • Good problem solving, analytical, organization, and time management skills.
  • Must demonstrate initiative, flexibility, and be able to work well in a team environment.
  • Demonstrated knowledge of clinical data flow and research design.
  • Clinical database administration and system validation experience.
  • Demonstrated competence with GCP/regional regulatory guidelines, SOPs (including WPs), medical terminology, standard coding dictionaries, and demonstrated proficiency in applying them to all relevant therapeutic areas.
  • CRO management experience, including a thorough knowledge of CRO audits.

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