Clinical Data Coordinator

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🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Data Coordinator

👻 Ghost score 12%

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Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 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.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Company benefits package • Ongoing learning and development • Attractive advancement opportunities • Stimulating work environment

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