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Clinical Data Manager

  • Anywhere

Company :
Statistics & Data Corporation (SDC)

Location :
Waltham, Massachusetts

Expiry Date :
Sun, 20 Jun 2021 23:59:59 GMT

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Description :
Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout either as a study lead or backup data manager. Manages the day-to-day data management project activities including, but not limited to, timelines, budgets, staff, project scope, reports, and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Analysts.

Primary Responsibilities

* Perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
* Allocate and prioritize workloads for multiple projects (media control, data entry, pre entry review and query management tasks)
* Serve as a primary or backup resource for issues pertaining to data management
* Serve as an interim resource for issues pertaining to the study in the absence of the Project Clinical Data Manager
* Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities
* Mentor all levels of Clinical Data Analysts in their job responsibilities
* Maintain quality control of the data, project deliverables and closeouts
* Support and facilitate the review of medical coding for validity and completeness
* Adhere to all aspects of the SDCs quality system
* Comply with SDCs data integrity & business ethics requirements
* Perform other related duties incidental to the work described herein
* Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

* Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process
* Excellent organizational and project management skills
* Able to lead teams to complete projects
* Highly effective communication skills, both written and verbal
* Technical skills including EDC systems, clinical data management systems, Microsoft Office
* Additional required skills include the following: CRF design, MS Project, and analytical capabilities.
* Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Education or Equivalent Experience

* Masters degree (preferably in engineering, applied or life science) and at least three (3) year of experience in clinical data management or
* Bachelors degree and at least four (4) years of experience in clinical trials, or
* Current Certified Clinical Data Manager (CCDM) status and at least four (4) years in clinical trials