Clinical Data Manager
Hyderabad, Telangana, India
Applications have closed
Statistics & Data Corporation (SDC)
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
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