Data Manager (Expert in Programming & developing EDC systems)
Data Manager responsible for EDC system validation, DM reporting, and database reconciliation in global trials.
Remote • Pune, Maharashtra, India
- Full Time
- Min. 4 YOE
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Data Manager responsible for EDC system validation, DM reporting, and database reconciliation in global trials.
Regulatory leadership for medium/high complexity projects, ensuring timely regulatory deliverables and compliance with procedures.
Lead regulatory intelligence projects, ensuring timely deliverables and budgeting for medium/high complexity work.
Assists ICSR management activities under supervision, processing safety reports and follow-up to meet timelines.
Oversees PSMF creation, revision, and quality checks for pharmacovigilance systems across client bases.
Launch your career in TMF management with ALCOA+ and SOP-compliance in an international team.
Entry-level TMF assistant role focusing on ALCOA+ and SOP compliance to support audits and CAPA plans.
Senior PSMF Officer with responsibility for creation and maintenance of PSMF documents and quality checks in pharmacovigilance.
Entry-level accounting role managing invoices, bank reconciliation, and intercompany coordination for a CRO with global operations.
Mandarin-fluent clinical project manager leads early-phase oncology trials and bid defense on a flexible contract.
Defines and drives enterprise architecture strategy and technical roadmap enabling AI-enabled, compliant, secure systems.
リードするICS R管理チームとプロジェクト全体の進捗・品質を管理。クライアントと協力体制を構築。
Provide approved medical information responses in German and English and document adverse events to support pharmacovigilance.
Lead regulatory intelligence projects, coordinate deliverables, and provide regulatory strategy within Pharmacovigilance and QA.
Acting as primary contact for project-related matters and managing client expectations to ensure satisfaction with PrimeVigilance services.
Supports pharmacovigilance activities within a project team with training provided.
Provide regulatory intelligence screening, manage database updates, and guide internal teams on national requirements.
Leads project management teams to deliver PV activities on time, budget, and quality for PrimeVigilance clients.
Senior specialist leads regulatory and PV deliverables per regulatory plan, liaises with partners and clients to ensure compliance.
Leads ICSR team, manages workflow, and drives KPI improvements for pharmacovigilance projects.
Leads ICSR team, manages workflow, and ensures KPI-driven pharmacovigilance activities for client projects.
Provide approved responses to medical inquiries in English, document adverse events, and support 24/7 medical information services.
Oversees pharmacovigilance projects, manages client expectations, and plans scope, milestones, and monthly reporting.
未経験者向けの研修制度あり。ICSR受領・返信・トラッキング・ファイリングや定期報告書作成補助などを担当。