Senior Clinical Data Manager
Location :San Jose ,CA
Client :Big CRO
Contract :12 Months Possible Extension
Job Description Summary
- Prepare Data Management Plan (DMP), Reconciliation Plan, Quality Control Plan, Coding Plan, Validation Plan, Communication Plan and other documentation as required.
- Perform data cleaning activities including developing, reviewing, and processing Data Clarification Forms (DCF)/query tracking.
- Organizing and conducting scheduled cross-functional data review and reconciliation, identification of data issues and tracking through resolution.
- Carry out database build and database validation as well as review and execute User Acceptance Testing of clinical databases.
KNOWLEDGE & SKILL REQUIREMENTS
- 10 years data management experience, or B.S./B.A. in a science or technical discipline degree with 6 years data management experience, or MS degree with 4 years data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment
- Meet the requirements of a Clinical Data Manager II with a high degree of proficiency and autonomy
- 3 years’ experience supervising Clinical Data Managers and team activities
- Ability to program in SQL or SAS desirable, but not required
- Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes
- Excellent oral and written communication skills
- Ability to work in a collaborative and multi-disciplinary environment
RESPONSIBILITIES
The main responsibilities of this role include but are not limited to the following:
- Manage all phases of data management activities and support to internal project teams, clients and Clinical Research Organization (CRO) including the following:
- Review and approve study startup documents, Data Management Plan (DMP), Reconciliation Plan, Quality Control Plan, Coding Plan, Validation Plan, Communication Plan and other documentation as required.
- Supervise data cleaning activities including processing Data Clarification Form (DCF)/query tracking and conducting and orchestrate scheduled cross-functional data review/reconciliation, identification of issues and track through resolution Design and/or approve final Electronic Case Report Form (eCRF)/Case Report Form (CRF), edit check specifications, case report form guidelines and electronic data handling conventions
- Manage database build activities, database validation and review and execution of User Acceptance Testing of clinical databases
- Facilitate internal study team, client and CRO meetings
- Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities
- Assist manager in monitoring timelines and managing resources to meet timelines
- Identify inconsistencies and inefficiencies in data management processes and recommend solutions
- Direct team members in daily activities including training and supervising Clinical Data Managers I and II
Company Description:Welcome to a Top-rated Scientific Talent Solutions Company. Madagoni LLC is a leading staffing and Talent solutions Company located in New jersey to serve in the mainly field of Scientific area such as Life sciences and Information technology around the United states. We do supply quality human resources for highly skilled match with our great customers requirement who are greatest and larger companies in the market. Our extensive and experienced operational team and recruiters get best talents from best job portals for perfect match for customer requirement.
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We do train for Newly graduates for different areas of Software and mechanical engineers based on the interesting and capability. We have industry expert trainers for remote training mockup interviews and help them to get best jobs in the market.
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