Gestionnaire de données cliniques – Clinical Data Manager

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🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 • Act as data management liaison to project teams, sponsors, and external vendors • Manage up to three studies with manager support • Attend sponsor meetings and answer data management questions • Monitor timelines, scope, budgets, enrollment, and study data status • Develop eCRF specifications, data capture screens, and edit checks for clinical databases/EDC systems • Program, maintain, validate, and test clinical databases, including UAT • Develop eCRF completion guidelines and training materials • Train site users and monitors on clinical databases • Develop data transfer agreements and specifications with external data vendors • Reconcile external data, EDC data, and sponsor safety databases when needed • Support ePRO and IWRS system development and document/test data transfers • Develop data management plans and related documentation • Perform ongoing data review and cleaning through database lock/close • Code medical terms as required • Generate data listings and reports for data review • Maintain complete, current data management documentation in the TMF • Respond to EDC user assistance requests • Archive clinical databases and related documents • Support data management work instructions • Mentor and train a Clinical Data Coordinator • Oversee outsourced vendors to ensure compliant timelines and deliverables

🎯 Requirements

• B.Sc. in science or 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 biotechnology, pharmaceutical, or CRO clinical research • 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 database programming skills are an asset • Knowledge of CDISC SDTM/CDASH standards • Strong 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 organize and prioritize multiple competing demands in a fast-paced environment • Knowledge of MedDRA and WHODrug dictionaries • Good knowledge of Good Clinical Practices and applicable Health Canada and FDA regulations/guidelines • Legally authorized to work in Canada

🏖️ Benefits

• Flexible work schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Full benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transit discounts, social activities) • Permanent full-time position