Senior Clinical Data Manager

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $110k - $130k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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eClinical Solutions

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2012

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

💰 Private Equity Round on 2020-01

Consulting • Healthcare • Biotechnology

eClinical Solutions is a clinical data management company that provides integrated data review and management solutions for the biotech and pharmaceutical industries. Their platform, elluminate, empowers organizations to modernize and automate their clinical data workflows, ensuring efficient data acquisition, management, and analysis. By leveraging advanced analytics and technology-driven approaches, eClinical Solutions helps streamline trial operations and improve productivity, enabling better decision-making in clinical research.

📋 Description

• Independently act as study lead for assigned clinical trial projects • Oversee, maintain, and manage clinical trial databases throughout the full data management lifecycle • Serve as the primary liaison between eClinical Solutions and sponsor personnel • Create and oversee database design specifications, validation, maintenance/data cleaning, and closeout activities • Monitor study timelines and deliverables • Ensure overall quality, efficiency, and consistency of data management activities • Communicate with global study teams • Participate in kickoff, closeout, and lessons-learned meetings • Create and present Investigator Meeting materials • Develop and deliver Sponsor CRA and/or site training • Delegate tasks and guide study data management teams • Oversee or develop data management documents, IST plans, testing, UAT packages, data reviews, QC checks, vendor reconciliations, queries, reports, metrics, and specifications • Track issues through resolution and identify data issues or trends • Maintain study documentation and perform database freeze/lock activities • Participate in process improvement, SOP/WI/training-material development, mentoring, proposal defenses, and other management-requested duties

🎯 Requirements

• Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred • 8+ years in Clinical Data Management experience preferred • Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology • Strong project management experience and project team leadership skills, including work planning and work delegation • Experience with EDC and performing data management activities • Excellent verbal and written communication skills • Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel • Experience with EDC and Clinical Data Management Systems

🏖️ Benefits

• Remote work • Professional development and career growth opportunities • Work-life balance • Inclusive culture • Equal opportunity employment