Sr. Clinical Data Associate Job in Rockville 20847, Maryland US
Represents the Data Management Department on clinical project teams and manages the data management aspects of clinical projects.
Ensures accurate and consistent handling of clinical data, as well as ensuring that data management tasks are conducted according to applicable SOPs and GCP guidelines.
Job Responsibilities: 70%
Responsible for reviewing protocols for clinical trials.
Complies with enforced standards from FDA and coordinates related parties.
Keeps milestones in the timeline of the project, including assuring databases are locked on time.
Liaises with Programming to ensure development of database, data entry screens, and edit check programs.
Manages user acceptance testing of databases and software.
Assists in data acquisition from external sources, eg central laboratories and CROs.
Provides input for Case Report Form Development.
Performs Database Setup activities for both paper and Electronic Data Capture trials.
Performs Data Cleaning activities for both paper and Electronic Data Capture trials.
Proactively identifies and implements opportunities for process improvement.
Performs Database Release and Lock activities for both paper and Electronic Data Capture trials.
Manages vendors according to the protocol, troubleshoots vendor accuracy and competence.
15%
Functions as Data Management representative on clinical project teams.
Provides progress reports and data reports to the team.
Provides data management expertise to the team to illustrate potential issues and offers proactive solutions.
Makes presentations at in-house, regional CRA, and/or Investigators meetings to ensure understanding of data management issues.
15%
Liaises with CRAs and Monitors to provide information on all study management issues.
Provides guidance to and directs the activities of CDC IIs and contract CDCs.
Provides input in the development of departmental standards and operating procedures.
Ensures all activities are conducted under applicable GCP and regulatory guidelines.
Ensures compliance with corporate and departmental SOPs.We are urgently seeking a Sr. Clinical Data Associate with a 4 year degree (minimum) and at least 6 years of work experience for our client in Rockville, Maryland.
EDC is mandatory, and Leadership and Management experience highly desired., Not Specified
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