Senior Clinical Data Manager

🕒 il y a 9 jours

🌐 Royaume-Uni, États-Unis – Distant

🇬🇧 Royaume-Uni – Télétravail 🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

Cette entreprise a parrainé des visas de Travailleur Qualifié du Royaume-Uni par le passé.

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Jazz Pharmaceuticals

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1001 - 5000 employés

Fondée en 2003

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals est une entreprise biopharmaceutique dédiée au développement de médicaments innovants répondant à des besoins médicaux sérieux non satisfaits. Avec un fort engagement envers la recherche et le développement, Jazz se concentre sur la création de thérapies transformatrices, mettant en avant l'importance de la collaboration, de la diversité et de l'engagement des employés dans ses opérations. L'entreprise est fière de transformer la vie des patients grâce à ses offres de produits significatives et une culture qui favorise l'enthousiasme et la flexibilité.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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

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