Senior Clinical Data Manager

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🌐 Poland, India – Remote

🇵🇱 Poland – Remote 🇮🇳 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

• Ensure data captured in multiple clinical trials is collected, managed, and reported clearly, accurately, and securely • Lead data management activities across studies from protocol review through database lock • Monitor study status, including enrollment and CRF monitoring/approval • Present deliverables to clients, gather feedback, and propose solutions • Provide regular data status reports to the project team • Oversee Clinical Data Coordinator work for quality and timeliness • Oversee vendors to ensure timelines and deliverables meet sponsor and protocol requirements • Maintain the clinical database, including data review and cleaning during study conduct and database lock preparation • Reconcile external data with EDC data, including sponsor safety databases for adverse events and serious adverse events • Develop data management plans • Design eCRFs and build clinical databases in the selected EDC • Coordinate clinical database validation and user acceptance testing • Support development of external clinical data systems such as ePRO or IWRS and document/test data transfers • Develop eCRF completion guidelines and training materials • Train site users and monitors on the clinical database • Activate/deactivate database users and maintain request records • Respond to users needing EDC assistance • Generate data listings and reports for data review before database close/lock • Ensure data management documentation is complete and current in the TMF • Archive the clinical database and related documents

🎯 Requirements

• B.Sc. or M.Sc., or in a related field of study • 7 years of clinical data management experience in the pharmaceutical industry or in a CRO environment • 3 years of experience as a lead data manager • Extensive experience working with EDC systems • Experience with Medrio and Medidata Rave preferred • Highly organized and detail-oriented • Project planning and time management skills • Strong verbal and written communication skills in English • Understanding of the drug development process and applicable regulations, including Good Clinical Practices (GCP) and ICH Guidelines • Good understanding of CDISC SDTM/CDASH standards • Knowledge of MedDRA and WHODrug dictionaries is an asset • Must be legally able to work in Poland

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Attractive advancement opportunities • Equitable treatment and equal opportunity • Recruitment and selection accommodations for applicants with disabilities upon request