Clinical Data Manager

Job not on LinkedIn

🔥 2 minutes ago

🇵🇭 Philippines – 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

• Provide general data management support to project teams, sponsors, and external vendors • Develop eCRF specifications, including data capture screens and edit check specifications • Program, maintain, validate, and test clinical databases and EDC systems • 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 with EDC data and sponsor safety databases when needed • Support development of external clinical data systems such as ePRO and IWRS 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 in clinical databases as required • Generate data listings and reports for data review and database close/lock • Monitor study status and provide data status reports • Maintain complete and current data management documentation in the TMF • Activate/deactivate database users and maintain request records • Respond to users needing EDC system assistance • Archive clinical databases and related documents • Participate in writing and updating data management SOPs • Mentor and train a Clinical Data Coordinator • Oversee outsourced vendors to ensure timelines, deliverables, sponsor requirements, protocol requirements, work orders, and SOPs are met

🎯 Requirements

• B.Sc. or in a related field of study • M.Sc. or in a related field of study is an asset • Between 5 to 10 years of clinical data management experience in clinical research in the biotechnology, pharmaceutical, or contractual research organization (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, including demonstrated skills in database programming • 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 • Excellent problem solving abilities • Ability to work in a fast-paced environment 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 authorized to work in the Philippines

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Attractive advancement opportunities • Home-based work location