Clinical Data Manager

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🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 12%

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

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

• Lead and manage clinical studies, ensuring data are collected, managed, and reported clearly, accurately, and securely • Ensure clinical data management activities conform to regulatory requirements, industry guidelines, SOPs, sponsor requirements, and timelines • Serve as the data management liaison to project teams, sponsors, and external vendors • Manage up to three studies based on study complexity • Attend sponsor meetings and answer data-management-related questions • Monitor timelines and scope of work for timely, on-budget completion • Develop eCRF specifications, data capture screens, and edit-check specifications for clinical databases/EDC systems • Program, maintain, validate, and test clinical databases, including User Acceptance Testing • Develop eCRF completion guidelines and training materials; train site users and monitors • Develop data transfer agreements and specifications with external-data vendors • Reconcile external data with EDC data and sponsor safety databases when needed • Support development of external clinical-data systems such as ePRO and IWRS, and document and test data-transfer requirements • Develop the data management plan and related documentation • Conduct ongoing data review and cleaning through database lock/close • Code medical terms in the clinical database • Generate data listings and reports for data review and database close/lock • Monitor study status and provide data-status reports to project teams • Maintain complete, current data-management documentation in the TMF • Respond to EDC system users requiring assistance • Archive clinical databases and related documents • Support writing and updating data-management Work Instructions • Mentor and train a Clinical Data Coordinator • Oversee external service providers to ensure timelines, deliverables, work orders, sponsor requirements, protocol requirements, and SOPs are met • Perform other assigned responsibilities when qualified and adequately trained

🎯 Requirements

• B.Sc. or in a related field of study • 3 to 5 years of clinical data management experience, or at least 1 year of lead clinical data manager experience in clinical research in the biotechnology, pharmaceutical, or CRO industry • Understanding of the drug development process and applicable regulations, including Good Clinical Practices and ICH Guidelines • Extensive experience working with EDC systems and/or database structures • Demonstrated skills in database programming are an asset • Good understanding of CDISC SDTM/CDASH standards • 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 • Excellent problem-solving abilities • Knowledge of SAS or similar is an asset • Working knowledge of MS Excel • Ability to work in a fast-paced environment and organize and prioritize multiple competing demands • Knowledge of MedDRA and WHODrug dictionaries • Good knowledge of good clinical practices and applicable Health Canada and FDA regulations/guidelines • Must be legally able to work in Canada

🏖️ Benefits

• Flexible work schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request