Clinical Data Manager

Hyderabad, Telangana, India

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Statistics & Data Corporation (SDC)

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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.

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 working closely with the lead Clinical Data Manager(s) and/or Clinical Data Analyst(s). Manages the day-to-day data management project activities including, but not limited to, study start-up, conduct, timelines, metrics, reports and communication for the lifecycle of the project(s).

Requirements

Required Skills:

  • Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process preferably at a CRO or pharma company
  • Excellent organizational and project management skills
  • Able to take lead and work independently to complete all OM activities
  • Highly effective communication skills, both written and verbal
  • Technical skills includinq: EDC systems (Medidata Rave and/or iMedNet preferred), , 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

  • Bachelor's degree and a minimum of four (4) years of experience in clinical data management, , or an equivalent combination of relevant education and/or experience with current Certified Clinical Data Manager (CCDM)

Tags: Consulting Data management GCP Research Statistics

Region: Asia/Pacific
Country: India
Job stats:  5  1  0
Category: Leadership Jobs

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