Associate Clinical Data Manager

Hyderabad, Telangana, India

Applications have closed

Statistics & Data Corporation (SDC)

View company page

Associate Clinical Data Manager

Statistics & Data Corporation (SDC), A global contract research organization (CRO) headquartered in Arizona, providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS.

No. of Openings: 3

Job Summary

Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout as a study lead with some supervision from their line manager or as a backup data manager. Manages the day-to-day data management project activities including, but not limited to, timelines, budgets, project scope, reports and communication for the lifecycle of the project(s) working closely with internal team members and clients/partners.

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.
  • Perform/Manage study conduct activities including listing reviews, query management, data transfers etc.
  • Perform study closeout activities leading towards database lock.
  • Serve as a primary or backup resource to other Clinical Data managers for issues pertaining to data management on multiple studies
  • Assist 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 SDC’s quality system
  • Comply with SDC’s 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

    Required Skills

  • Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process
  • Excellent organizational and project management skills
  • 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

  • Master’s degree (preferably in engineering, applied or life science) and at least one (1) year of experience in clinical data management or bachelor’s degree and a minimum of three (3) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status.
  • Tags: Classification Consulting Data management Engineering GCP Research Statistics Testing

    Region: Asia/Pacific
    Country: India
    Job stats:  11  5  0
    Category: Leadership Jobs

    More jobs like this

    Explore more AI, ML, Data Science career opportunities

    Find even more open roles in Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), Computer Vision (CV), Data Engineering, Data Analytics, Big Data, and Data Science in general - ordered by popularity of job title or skills, toolset and products used - below.