Clinical Data Manager - II

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Allucent

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Drug Development • Regulatory Affairs and Submissions • Clinical Strategy • Cell & Gene Therapy • Rare Diseases & Orphan Indications

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies navigate clinical trials. • We are looking for a Clinical Data Manager II to join our team. • Assist in data management activities related to database design, cleaning, and reporting. • Ensure clinical data meets quality standards and regulatory requirements. • Collaborate with Lead DMs, Clinical Programmers, Data Scientists, and others. • Act as primary contact for DM with internal and external parties. • Develop, review, and maintain project-specific DM documents. • Provide support during clinical study database set-up and User Acceptance Testing (UAT). • Create training materials for EDC users and review clinical data. • Monitor tasks against budget and project timelines. • Participate in the review of study documents, create reports, and assist in quality checks. • Ensure good communication and relationships with clients. • Contribute to improving processes in the Quality Management System. • Actively support staff learning & development within the company.

Requirements

• Bachelor's degree in Life sciences • Post Graduate degree from local university • 5+ years of relevant work experience as Clinical Data Manager • 5+ years of experience in drug development and/or clinical research • 5+ years of EDC experience in Medidata Rave, Merative/Zelta-IBM) • Clinical trial data experience specializing in various therapeutic areas such as: oncology, autoimmune, immunology, hematology, rare diseases, etc. • Good knowledge of ICH-GCP, GDPR/HIPPA and applicable (local) regulatory requirements • Good understanding of Medical Terminology • Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, familiar with IRT and eCOA • Active participation and support in Data Management activities related to database setup, data cleaning and query management, external data reconciliation for at least 3 studies. • Good understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation • Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models • Strong written and verbal communication skills including good command of English language • Representative, outgoing and client focused • Ability to work in a fast-paced challenging environment of a growing company • Proficiency with various computer applications such as Word, Excel, and PowerPoint required • Administrative excellence • Eye for detail, strong technical, analytical and problem-solving skills • Good project management skills • Ability to translate guidelines, rules and regulations in clear and usable recommendations • Ability to simplify complex issues into understandable concepts

Benefits

• Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/hybrid* working depending on location • Leadership and mentoring opportunities • Participation in our Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via GoodHabitz and internal platforms