
201 - 500 employees
đ Pharmaceuticals
đĽ Healthcare
đź Consulting
Pharmaceuticals ⢠Healthcare ⢠Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
đĽ 0 minutes ago
đŽđł India â Remote
â° Full Time
đĄ Mid-level
đ Senior
⨠Clinical Data Coordinator
đť Ghost score 12%
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201 - 500 employees
đ Pharmaceuticals
đĽ Healthcare
đź Consulting
Pharmaceuticals ⢠Healthcare ⢠Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
⢠Participate in clinical data management activities for clinical trials undertaken or managed by Indero ⢠Ensure clinical trial data is collected, managed, and reported clearly, accurately, and securely ⢠Conduct activities in conformance with regulatory requirements, industry guidelines, Indero SOPs, sponsor requirements, and timelines ⢠Provide general data management support to the project team, sponsor, and external vendors ⢠Support the Lead Data Manager with data review, data reconciliation, discrepancy management, study metrics maintenance, and study status monitoring ⢠Provide data status reports to the project team as needed ⢠Generate ad-hoc study reports ⢠Perform user maintenance ⢠Assist with user acceptance testing ⢠Assist with database design ⢠Assist with creating the data management plan and related documentation ⢠Assist in ensuring data management documentation is complete and up to date in the trial master file
⢠B.Sc. or related field ⢠1 year of clinical data management experience in the pharmaceutical industry or in a CRO environment is considered an asset ⢠Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset ⢠Skilled in use of computer technology, and ability to learn new applications ⢠A general knowledge of CDASH/SDTM is considered an asset ⢠Highly organized and detail-oriented with effective project planning and time management skills ⢠Strong verbal and written communication skills in English; French is an asset ⢠Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands ⢠Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment ⢠Understanding of the drug development process and applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines ⢠Legally authorized to work in India
⢠Flexible work schedule ⢠Permanent full-time position ⢠Company benefits package ⢠Ongoing learning and development ⢠Attractive advancement opportunities ⢠Stimulating work environment
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