
Clinical Data Manager – Contract
Posted Sep 17

Posted Sep 17
This is a fully remote position, open to applicants in Massachusetts.
• Act as the primary liaison for data management between eClinical Solutions and sponsors, facilitating all relevant interactions.
• Ensure adherence to eClinical Solutions' data management protocols while delivering high-quality results within established timelines and approved scopes.
• Outline study requirements encompassing Protocol Conversion, Database Construction, CRF design, Data Entry, Data Verification, Data Review, and Query Management.
• Specify requirements and work alongside the technical team to configure elluminate for data-cleaning strategies and oversight functions.
• Conduct quality control checks on study documentation, programming and reporting specifications, deliverables, and elluminate modules.
• Execute comprehensive data reviews and trend analyses through reporting and elluminate analytics to identify potential issues and risks, and formulate mitigation strategies.
• Oversee and analyze KPIs, metrics, dashboards, and reports to enhance processes and efficiency.
• Undertake additional responsibilities as needed.
• Preferred 5+ years of experience in Clinical Data Management.
• A Bachelor’s degree in a health-related discipline or equivalent experience is preferred.
• CCDM Certification is preferred.
• Strong project management expertise and leadership capabilities in project teams, including work planning, delegation, and complex problem-solving.
• Excellent analytical and strategic thinking abilities.
• Detail-oriented with skills in multitasking, prioritization, planning, and organization.
• Exceptional collaborative capabilities.
• Proficient command of the English language, with strong verbal and written communication skills.
• Proficient in Microsoft Office Applications, particularly MS Project and MS Excel.
• Familiarity with ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.
• Proficient in EDC and Clinical Data Management Systems.
• Experience with Cloud SaaS platforms is preferred.
• Familiarity with data reporting tools such as Qlik, JReview, and Spotfire is preferred.
• Experience with RBQM methodology is preferred.
• Exposure to CDISC guidelines and standards.
• Recognition for remote work and prioritization of work-life balance.
• An inclusive culture that values people first.
• Opportunities for learning, growth, and continuous improvement.
• Access to company-approved AI tools to enhance productivity and quality.
• Commitment to equal opportunity employment.
Thermo Fisher Scientific
ICON plc
ICON plc
Clinical Outcomes Solutions
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