This job has expired

This position was posted on January 16, 2026 and is likely no longer accepting applications. We've kept it here for historical reference. Check out the similar jobs below!

Lead Data Manager - FS

Premier Research Group Limited

Job Overview

Location

Regional_Bulgaria

Job Type

Full-time

Full Job Description

📋 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

Ready to Apply?

Apply Externally

You will be redirected to an external site to apply.

Premier Research Group Limited

Visit Website

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.

View Company Profile

Get more remote jobs like this

Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.

Weekly remote jobs and featured talent.

No spam. Only curated remote roles and product updates. You can unsubscribe anytime.