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Company: MedStar Medical Group
Location: Hyattsville, MD
Career Level: Mid-Senior Level
Industries: Not specified
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Description

Effectively manages the project team, ensuring on-time, within budget, quality performance and delivery of projects. Oversees and coordinates the daily activities of data entry and associated data management tasks outside of the functions for the Center for Databases and Programming Technologies as outlined below.
Education

  • Master's degree in Health Care Field or Life Sciences required
Experience
  • Excellent working knowledge of FDA, ICH, GC and other regulatory functions required
  • 3-4 years Experience in phase I-IV (or pivotal) clinical trials and knowledge of medical field required
Knowledge, Skills, and Abilities
  • Proficiency with basic computer programs and exposure to relational databases.
  • Must possess excellent writing skills and ability to communicate effectively with staff and management.
  • Excellent problem-solving skills and ability to exercise independent judgment.
  • Business acumen and leadership skills.
  • Strong verbal and written communication skills with ability to effectively interact with all levels of management, internal departments and external agencies.
  • Working knowledge of various computer software applications.
  • Develops department goals, objectives, policies, and procedures. Ensures compliance with business unit policies and procedures and governmental and accreditation regulations.
  • Develops and recommends department operating budget and manages resources according to approved budget.
  • Selects, trains, orients, and assigns department staff. Develops standards of performance, evaluates performance, and conducts performance management planning. Initiates or makes recommendations for personnel actions. Maintains ongoing communication with subordinates to review programs, provide feedback, discuss new developments, and exchange information.
  • Manages the day to day activities of the research data coordinators, project leads, and research assistants and Plans, organizes and manages all aspects of the assigned clinical trial.
  • Leads and manages the efforts of all key functional departments to perform all project-related activities according to project milestones by overseeing and managing the Standard Operating Procedures for Data Management (DM) within MCRN's Data Center and facilitates the DM plans, edit checks and related requirements for study-level data lock.
  • Liaises with scientific leads on the development and implementation of data repositories for current and future work leveraging existing and new data requirements.
  • Ensures sufficient regulatory oversight for all internal database activities.
  • Prepares monthly status reports for monthly project review meetings.
  • Liaises with sites on a day to day basis, ensuring subject recruitment milestones are met.
  • Oversees and collaborates with Center for Databases and Programming Technologies in case Report Form design. Collaborates with the Center for Databases and Programming Technologies in preparation of building, deployment, queries and final report generation.
  • Communicates with internal departments and external organizations regarding database design and implementation.
  • 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, and entry data clarification responses and investigating data anomalies.
  • Manages and prepares materials for both clinical events committee and data safety monitoring boards as applicable.
  • Collaborates with the Biostatistical team on the development of standardized variable exports for both retrospective and prospective databases.
  • Maintains awareness, and possess working knowledge, of applicable federal, state, local, and other regulations and guidelines pertaining to research. Implements and applies these regulations in the conduct of research work to ensure the highest quality research activities from site selection through study closure.
  • Develops complete accurate data entry tools established protocol and project timelines once for all databases and studies/trials. Prepares for study audits visits, as applicable. Completes all data queries within the timeframe preferred and/or required by sponsor. Ensures accuracy and completeness of information (both electronic and paper forms).
  • 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.
  • Participates in meetings and on committees and represents the department and business unit in community outreach efforts.
  • Participates in multidisciplinary quality and service improvement teams and maintains effective working relationships with other departments.
  • Performs other duties as assigned.


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