Senior Clinical Data Manager

🔥 19 minutes ago

🌐 United Kingdom, United States – Remote

🇬🇧 United Kingdom – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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This company has sponsored UK Skilled Worker visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Lead complex clinical studies or related study series with minimal guidance • Lead data management activities for early phase healthy-volunteer clinical pharmacology studies, including SAD, MAD, food effect, drug-drug interaction, bioavailability, bioequivalence, and first-in-human studies • Represent Data Management on assigned study teams • Manage data management activities, vendors, and CRO progress for assigned studies • Collaborate with Medical Monitors, Clinical Pharmacologists, Statisticians, Phase I-unit teams, and CRO counterparts on real-time review of safety, PK, PD, ECG, laboratory, and biomarker data • Review protocols, schedules of assessments, data capture requirements, eCRFs, and eCOA forms • Design and test EDC systems and resolve EDC system issues • Support eCOA and IRT system setup • Lead development of data edit check specifications and data listings • Develop or lead development of clinical study Data Management documents • Review and provide feedback on clinical monitoring plans, statistical analysis plans, and vendor specifications • Provide EDC, eCOA, and eCRF completion guideline training • Lead database upgrades and migrations, including User Acceptance Testing • Enter and manage resolution of site data queries • Reconcile external data sources and Serious Adverse Event data against the clinical database • Perform database freeze and lock activities • Maintain the study eTMF • Generate study timelines and manage Data Management activities against them • Mentor and train junior Data Management staff • Assist with onboarding and training employees and contractors • Participate in Clinical Data Operations team meetings • Contribute to or lead process improvement initiatives, including SOPs, work instructions, and process documents • Apply Jazz Pharmaceuticals’ Code of Business Conduct and Ethics

🎯 Requirements

• At least five years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment • Minimum of two years leading Phase I (HV) studies • Study lead experience • Understanding of Phase 1-4 clinical studies and core Data Management tasks • Comprehensive understanding of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, and their application to Data Management • Project management skills and ability to prioritize across multiple tasks • Ability to work individually, within a multi-disciplinary team, and with external partners and vendors • Experience working with a globally distributed team • Good communication/interaction skills • Experience with Risk Based Monitoring principles and critical thinking to assess and manage risk • Strong English language written and verbal communication skills • Solid computer system and technical skills; ability to learn multiple computer applications • Prior experience with different Data Management systems, technologies, and Electronic Data Capture systems is desirable • Experience supporting Phase I HV Clinical Pharmacology or First-in-Human studies • Knowledge of reconciliation and quality review processes for bioanalytical, central laboratory, ECG, and other external vendor data • Experience supporting interim analyses, cohort reviews, and dose escalation decision-making processes • Experience with rapid database development, real-time data cleaning, and accelerated study execution timelines • Strong understanding of pharmacokinetic (PK), pharmacodynamic (PD), ECG, laboratory, biomarker, and other clinical pharmacology data • Experience in fast-paced early development environments where timely high-quality data is critical • BA/BS, preferably in the scientific/healthcare field • Able to travel to off-site meetings or training seminars as needed

🏖️ Benefits

• Medical, dental and vision insurance • Retirement savings plan • Flexible paid vacation • Eligibility to participate in various benefits offerings • Travel to off-site meetings or training seminars as needed