Senior Clinical Data Manager

Job not on LinkedIn

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🧪 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 multiple clinical studies, ensuring data are collected, managed, and reported clearly, accurately, and securely • Ensure activities conform to regulatory requirements, industry guidelines, company SOPs, sponsor requirements, and timelines • Serve as data management liaison to project teams, sponsors, and external vendors • Independently manage three to four concurrent studies with minimal supervision • Attend sponsor meetings and answer data management questions • Provide input for timelines and monitor scope of work for timely, budget-compliant completion • Develop eCRF specifications, including data capture screens and edit checks, for study-specific clinical databases and 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 and integration of external clinical data systems such as ePRO and IWRS • 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, reports, and data status reports for study teams • Monitor study status, including enrollment and CRF monitoring/approval • Maintain complete, current data management documentation in the TMF • Respond to EDC user assistance requests • Archive clinical databases and related documents • Define, write, and update data management Work Instructions • Mentor and train Clinical Data Coordinators and support less experienced Clinical Data Managers • Oversee outsourced data management vendors and ensure deliverables meet sponsor, protocol, work order, and SOP requirements

🎯 Requirements

• B.Sc. in a related field of study • 5 to 8 years of clinical data management 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 database programming skills 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 • Good knowledge of MS Excel • Knowledge of SAS or similar is an asset • Excellent problem-solving abilities • Ability to work in a fast-paced environment and organize and prioritize multiple competing demands • Knowledge of MedDRA and WHODrug dictionaries • Must be legally authorized to work in India

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Home-based work arrangement