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Clinical Data Coordinator – India (Remote)
Support clinical trial data review, reconciliation, and reporting at Indero, a dermatology and rheumatology contract research organization. Contribute to database management, study documentation, and regulatory compliance.
विवरण
- Support clinical data management activities for clinical trials undertaken or managed by Indero
- Maintain clear, accurate, and secure collection, management, and reporting of clinical trial data
- Perform work in line with regulatory requirements, industry guidance, Indero SOPs, sponsor requirements, and timelines
- Provide data management support to project teams, sponsors, and external vendors
- Assist the Lead Data Manager with data review, reconciliation, discrepancy management, study metrics, and status monitoring
- Prepare data status reports for the project team as needed
- Produce ad hoc study reports
- Maintain user access and records
- Support user acceptance testing
- Assist with clinical database design
- Help prepare the data management plan and related documentation
- Help keep data management documentation complete and current in the trial master file
आवश्यकताएँ
- Bachelor of Science degree or a related qualification
- At least one year of clinical data management experience in the pharmaceutical industry or a CRO environment is considered an asset
- Experience with an EDC system such as Medidata Rave or Medrio is considered an important asset
- Proficiency with computer technology and the ability to learn new applications
- General knowledge of CDASH and SDTM is considered an asset
- Strong organization, attention to detail, project planning, and time management skills
- Strong spoken and written English communication skills; French is an asset
- Ability to work in a fast-paced environment while managing and prioritizing competing demands
- Excellent interpersonal, communication, problem-solving, and organizational skills, with the ability to work independently and collaboratively
- Understanding of drug development and applicable regulations, including Good Clinical Practice, ICH Guidelines, and relevant Health Canada and FDA regulations or guidelines
- Legally authorized to work in India
लाभ
- Flexible working schedule
- Permanent full-time employment
- Company benefits package
- Ongoing learning and development
- Opportunities for career advancement
- Stimulating work environment
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