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Clinical Project Lead-Data Management

Company: Medstar Research Institute
Location: Washington
Posted on: June 12, 2021

Job Description:

Job Summary Effectively leads the project team, ensuring on-time, within budget, quality performance, and delivery of projects. # Minimum Qualifications Education/Training:######### Bachelor#s degree in Healthcare field or Life Sciences required. Master#s Degree in Healthcare field or Life Sciences is desired. Experience:######## 2 years of experience in Phase I-IV clinical trials and knowledge of medical field. License/Cert/Reg:############# No special certification, registration or licensure required. Knowledge, Skills # Abilities: Proficiency with basic computer programs, data analysis tools and exposure to relational databases. Must possess excellent analytical skills (orientation to data analysis and reports creation), writing skills and ability to communicate effectively with sponsors, staff and management. Strong organizational, leadership, and interpersonal skills with the ability to manage multiple, complex duties with close attention to detail required. # Primary Duties and Responsibilities Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards, and safety standards. Complies with governmental and accreditation regulations. Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner. Leads and manages the efforts of all key functional departments to perform all project-related activities according to project milestones. Prepares monthly status reports for monthly project review meetings. Collaborates with Center for MCRN Databases and Programming Technologies in case Report Form design, databases, and exports. Collaborates with Contracts and Regulatory team in site budget contracting. Collaborates with the Center for MCRN Databases and Programming Technologies in preparation of queries and final report generation. Collaborates with the statistical support within MCRN to ensure the needs of the Scientific Leads are met. Manages the following task completions: logging incoming case report forms, data clarification forms, edit checks, design and execution, serious adverse events notification, queries and study related report requests, resolution of data entry discrepancies, entry data. Communicates with internal departments and external organizations regarding database design and implementation. Leads and manages the efforts of all key functional departments to perform all project-related activities according to project milestones. Liaises with sites on a day to day basis, ensuring the projects on the Scientific Leads are met and executed with the set milestones. Manages and prepares materials for both clinical events committee and data safety monitoring boards as applicable. Organizes and prepares or directs the preparation of the monthly status reports for monthly project review meetings. Participates in meetings and on committees and represents the department and hospital in community outreach efforts. Participates in multi-disciplinary quality and service improvement teams. Performs other duties as assigned.

Keywords: Medstar Research Institute, Washington DC , Clinical Project Lead-Data Management, Other , Washington, DC

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