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Senior Clinical Data Manager

Ideal Consult • King of Prussia, Montgomery County, United States • $200k - $250k / year • 2h ago

King of Prussia, PA

Job Responsibilities:

Serves as the primary contact for internal team members regarding clinical data management data review activities and leads these review activities to ensure delivery of data fit for analysis.
Provides input into clinical system development activities, to ensure systems support the data review needs of the study, focusing on critical data and processes, and identified risks.
Ensures clinical data management review requirements are put into production per the study’s protocol risk evaluation and integrated data review plan (IDRP).
Contributes to the development and maintenance of study plans documents specifying data review strategy and applicable procedures on assigned protocols/projects.
Develops and oversees the timelines of clinical data management activities during the life cycle of studies.
Communicates and triages issues to appropriate roles for follow-up and action to address root cause.
Leads clinical data management activities on projects with diverse scope.
Leads and hosts the data monitoring meetings, communicating issues to the internal and external stakeholders in a meaningful way such as summarizing the data and representing the information visually.
Uses high level knowledge of the protocol, identifies critical data and processes from protocol review, and supports protocol risk evaluation process.
Coordinates with assigned project teams to communicate, address and resolve data related issues and recommends potential solutions; escalates issues which potentially impact patient safety or study analysis.
Trains and mentors new and less experienced team members.
Participates in CRO and/or third-party audits as required.
Develops and maintains data review study documentation as appropriate to facilitate data validation and analytics.

Additional Qualifications:

Bachelor’s degree in computer science or related fields.
Strong technology background and interested in cutting-edge solutions.
Organized, self-motivated, independent worker needing limited managerial oversight.
Team player who can communicate clearly and thoroughly.
Strong written and verbal communication skills.
Provides effective communication and coordination in development support.

Application Instructions:

Mail resumes to Ideal Consult LLC., ATTN: HR, 203 Brandenburg Way, King of Prussia, PA 19406.

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