Senior Clinical Data Manager

Jazz Pharmaceuticals

. Lead complex clinical studies or related study series with minimal guidance .

Posted 10/27/2026full-timeRemote • United Kingdom, United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading complex clinical studies and data management activities, particularly in early phase clinical pharmacology. Proficient in EDC systems, data reconciliation, and compliance with ICH/FDA regulations.

Highest-signal resume keywords

Data Management ExperiencePhase I Study LeadershipEDC System Design and TestingICH/FDA Guidance KnowledgeProject Management Skills

ATS Keywords

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Hard Skills

Clinical Data ManagementElectronic Data Capture (EDC)Pharmacokinetic (PK) AnalysisPharmacodynamic (PD) AnalysisData ReconciliationDatabase Freeze and Lock ActivitiesData Edit Check SpecificationsRisk Based MonitoringInterim Analyses SupportQuality Review Processes

Soft Skills

Good Communication SkillsCritical ThinkingTeam CollaborationMentoring and TrainingProblem Solving

Tools & Technologies

ECRFECOAIRT SystemsData Management SystemsStatistical Analysis Tools

Industry Keywords

Pharmaceutical IndustryBiotechnologyFDA-Regulated EnvironmentICH StandardsCDISC StandardsGCDMP21 CFR 11MedDRAWHO Drug DictionariesClinical Pharmacology

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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