Job Description
Clinical Data
> Management. Please go through it and let me know if you have any
> suitable consultants available on your bench.
>
> Role: Manager, Clinical Data Management - 1102
> Location: REMOTE
> Contract: 6 months with possible renewal
>
> Experience: 12+ Years
>
> The candidate should have direct line management experience of at
> least 4+ years, managing
> 3-4 direct reports.
>
> JOB DESCRIPTION / SUMMARY & RESPONSIBILITIES :
>
> The main responsibilities of this role include but are not limited to
> the following:
>
> * Provide data management expertise and support to internal project
> teams, clients and Clinical Research Organizations (CROs) including
> the following:
> * study startup documents, data cleaning, DCF/query tracking,
> database QC, compilation, and maintenance of data management binders
> and/or files, and SAE/AE reconciliation
> * Plan, perform and oversee development of specifications for
> eCRFs/CRF, edit checks, electronic data handling, manual review and
> execution of User Acceptance Testing
> * Conduct and orchestrate scheduled cross-functional data review,
> identification of issues and track through resolution
> * Participate in innovation and implementation of new technologies
> resulting in data management process improvements
> * Ensure adherence to quality control procedures for data management
> activities
> * Write appropriate Standard Operating Procedures (SOPs)/training
> * guidelines and oversee revisions /updates to current SOPs/training
> * guidelines for data management activities
> * Facilitate and oversight of 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 Director any requested out of scope
> activities
> * Manage and monitor timelines and assuring resources are available
> to meet timelines
> * Identify inconsistencies and inefficiencies in data management
> processes and recommend solutions
> * Assist in preparation of proposals and budgets for new projects as
> well as manage budgets for ongoing projects
> * Direct and manage team members in daily activities including
> providing
> * training, resource assignment, adherence to timelines and
> conducting annual performance review.
>
> KNOWLEDGE & SKILL REQUIREMENTS
>
> * - 12 years data management experience, or B.S. /B.A. in a science
> or technical discipline degree with 8 years data management
> experience, or MS degree with 6 years data management experience;
> minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO
> environment Meet the requirements of a manager with a high degree of
> proficiency and autonomy
> * 6 years' experience supervising Clinical Data Managers and/or
> 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
> * Good knowledge of Food and Drug Administration (FDA), Europe
> Medicines Association (EMA), International Conference on Harmonisation
> (ICH) guidelines and Good Clinical Practices (GCPs) including
> regulatory requirements for the conduct of clinical development
> programs, especially as related to data handling and processing.
>
>
>
> Thanks & Regards ?
>
> Prashanth
Employment Type: Full-Time
Job Tags
Full time, Contract work, Remote job,
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