Associate, Clinical Data Management

Job not on LinkedIn

🔥 5 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 11%

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Red Nucleus

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Red Nucleus is a company specializing in healthcare and life sciences services, offering a wide range of advisory and scientific services. With over three decades of experience, they provide solutions across the life sciences product life cycle, aiming to improve health outcomes. Their services include market access and commercialization, medical communications, and learning and development. Red Nucleus also offers products like DirectusPRO and iTakeControl. They focus on supporting strategic and operational challenges in healthcare through their expertise in areas like Quality, Clinical, Safety, Regulatory, and Medical Affairs. The company employs a team of over 700 members dedicated to advancing knowledge and improving lives.

📋 Description

• Manage and review clinical and ePRO data, including video-based data collection • Develop Data Management Plans, CRF Specifications, eCRFs, and study documentation • Support data transfers, exports, migrations, and reconciliation activities • Participate in site initiation visits, user acceptance testing (UAT), and product launches • Collaborate with sponsors, sites, vendors, and cross-functional teams • Support innovative approaches to remote data monitoring and patient-centric research • Support delivery and oversight of clinical and patient-reported data within EDC platforms, including iTakeControl (iTC) technology • Support studies from startup through closeout

🎯 Requirements

• Undergraduate degree or equivalent professional experience • Experience supporting clinical study protocols, protocol amendments, observational research, registries, data migrations, reporting, and data transfers • Professional experience within biopharma, pharmaceutical, CRO, clinical site, or consulting environments • Knowledge of GCP, ICH, HIPAA, GDPR, FDA requirements, FDA 21 CFR Part 11, Annex 11, and GxP processes • Experience with or understanding of EDC, ePRO, EHR, clinical research technologies, and health data collection systems • Experience managing multiple projects, timelines, stakeholders, vendors, and study teams simultaneously • Strong written and verbal communication skills • Proficiency in Microsoft Office (Word, Excel, PowerPoint) • Experience level of 0–10 years stated • Nice to have: digital health, digital therapeutics, or mobile application experience • Nice to have: experience in rare diseases, gene therapy, or long-term follow-up studies • Nice to have: experience working with central or specialty laboratories/vendors • Nice to have: familiarity with CDISC, CDASH, SDTM, FHIR, OMOP, MedDRA, and WHO Drug standards and dictionaries

🏖️ Benefits

• Equal opportunity and inclusive workplace commitment • Non-discrimination on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status