Job Overview
Location
Regional_Bulgaria
Job Type
Full-time
Category
Data & Analytics
Date Posted
January 16, 2026
Full Job Description
đź“‹ Description
- • Own the full data management lifecycle for global Phase I-III biotech and specialty pharma studies, translating complex protocols into clean, submission-ready databases that regulators trust and patients depend on.
- • Architect and configure EDC systems (Oracle RDC, Medidata Rave, DataLabs) from scratch—designing eCRFs, setting up edit checks, and writing data validation rules that catch discrepancies before they ever reach biostatistics.
- • Author and maintain the Data Management Plan, Data Validation Plan, CRF Completion Guidelines, and all associated SOP-compliant documentation; your documents become the single source of truth for cross-functional teams across three continents.
- • Lead user-acceptance testing (UAT) sessions with clinical operations, biostatistics, and sponsor counterparts; triage and resolve every bug or requirement gap before go-live, ensuring first-patient-in readiness on aggressive timelines.
- • Drive data cleaning excellence—generate intelligent queries, monitor query aging, and mentor junior data managers on discrepancy resolution tactics that keep database lock dates sacred.
- • Reconcile high-volume third-party data (central labs, eCOA, imaging, PK) against the CDMS; build automated reconciliation reports that surface outliers within 24 hours of data receipt.
- • Serve as the primary data management point of contact for FSP sponsors; present weekly metrics, risk-mitigation plans, and strategic recommendations that shape study-level decisions and strengthen long-term partnerships.
- • Curate the electronic Trial Master File (eTMF) in real time, guaranteeing inspection readiness at every interim analysis and regulatory submission milestone.
- • Coach, train, and quality-check the work of 3-5 data managers; create reusable macros, SOP addenda, and onboarding checklists that shorten ramp-up time for future studies.
- • Partner with Project Managers to forecast resourcing, flag scope creep, and negotiate timeline trade-offs so that every deliverable meets both Premier Research quality standards and sponsor expectations.
- • Champion continuous improvement by piloting new EDC features, participating in vendor user groups, and feeding lessons learned back into the FSP knowledge base.
- • Contribute to departmental initiatives such as SDTM mapping automation, data review dashboard enhancements, and risk-based monitoring integration—your innovations directly influence Premier’s next-generation data strategy.
🎯 Requirements
- • Bachelor’s degree (or international equivalent) in a technical, clinical, or health-related discipline; advanced degree or relevant certification (CDM, CCDM, PMP) preferred.
- • 3–5 years of hands-on experience leading end-to-end data management activities within commercial EDC environments—Oracle RDC, Inform, Medidata Rave, or DataLabs.
- • Demonstrated mastery of data management planning, CRF/eCRF design, edit check programming, query generation, and database lock procedures in accordance with GCP and 21 CFR Part 11.
- • Exceptional written and verbal English communication skills; proven ability to present complex data issues to both technical and non-technical stakeholders.
- • Advanced proficiency in Microsoft Office (Excel pivot tables, Word templates, PowerPoint storyboards) and familiarity with SQL or SAS for ad-hoc data investigations.
🏖️ Benefits
- • Flexible hybrid working model—split your week between home and our modern Sofia office, with core hours that respect work-life balance.
- • Annual performance bonus and stock purchase plan that directly link your contributions to Premier’s global success.
- • Comprehensive private medical, dental, and vision insurance for you and eligible dependents from day one.
- • Global learning stipend, internal mentorship programs, and paid attendance at leading industry conferences (SCOPE, CDISC, DIA) to accelerate your career trajectory.
Skills & Technologies
Senior
Onsite
Degree Required
Hybrid
About Premier Research Group Limited
Premier Research Group Limited is a global contract research organization (CRO) supporting biotech and pharmaceutical companies through clinical development services. The company provides expertise in early- and late-phase trials across therapeutic areas including oncology, rare diseases, neurology, pediatrics, and women’s health. Services span regulatory strategy, biostatistics, data management, site selection, patient recruitment, and post-market surveillance. Headquartered in Cary, North Carolina, Premier Research operates offices in Europe, Asia, and North America, delivering tailored solutions for small to mid-sized sponsors aiming to accelerate drug development and regulatory approval.
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