Principal Clinical Data Manager

Job not on LinkedIn

🔥 16 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $125k - $145k / year

⏰ Full Time

🔴 Lead

📊 Data Scientist

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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

• Primary representative for eClinical Solutions and sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved scope • Function as DM subject matter expert providing guidance on data management best practices, technology, and solutions • Provides study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management • Define specifications and collaborate with technical team on configuration of elluminate® for data cleaning strategy and oversight activities • Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate® modules • Perform quality oversight and data trending via elluminate® reporting and analytics to identify risks and develop mitigation and data cleaning strategies • Collaborate with technical and engineering teams on tech enabled solutions in areas for process and efficiency improvement • Collaborate with functional managers and training team to deliver training. • Other duties as assigned

🎯 Requirements

• Bachelor’s degree or higher (master’s in science preferred) in relevant health science or professional qualification in a relevant scientific/technical discipline preferred • 10+ years’ experience in Pharmaceutical/Biotechnology industry with Clinical Data Management or equivalent consulting role preferred • CCDM Certification preferred • Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems. Prefer experience with agile and six sigma methodologies • Strong consulting and client relationship management skills • Strong analytical and strategic thinking skills • Detail oriented, ability to multitask with strong prioritization, planning and organization skills • Excellent collaborative skills • Demonstrated command of the English language with proficiency in both verbal and written communication • Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel • Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology • Proficient with EDC and Clinical Data Management Systems • Experience with Cloud SaaS platforms (preferred) • Experience with data reporting tools such as Qlik, JReview, Spotfire (preferred) • Experience with RBQM methodology preferred • Exposure to CDISC guidelines and standards

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options