IT Business Analyst Project Manager

Somewhere; Johannesburg; Remote; ZAR 200,000 - 300,000; Full time

Job summary

Une entreprise dynamique recherche un(e) Analyste d'Affaires IT GxP & Chef de Projet pour améliorer l'alignement des technologies d'entreprise avec les stratégies commerciales essentielles. Le candidat idéal doit avoir un diplôme en sciences, une solide expérience en GxP et en gestion de projet, et être capable de travailler pendant les heures de bureau de l'Est des États-Unis. Cette position clé exige à la fois une vision stratégique et des compétences pratiques avec un accent fort sur la conformité réglementaire et l'amélioration des processus.

Qualifications

• Forte expérience en GxP et analyse commerciale.
• Compétence en gestion de projet et documentation des exigences.
• Compréhension des systèmes cliniques et de qualité.

Responsibilities

• Conduire la conception et l'implémentation de projets IT selon les méthodologies SDLC.
• Analyser et améliorer les systèmes et flux de travail commerciaux.
• Gérer le cycle de vie complet des projets réglementés par GxP.

Skills

Business Analysis

Project Management

Regulatory Compliance

Process Improvement

Cross-Functional Collaboration

Education

Bachelor’s degree in a science-related or technical field

Job description

Job Title : IT GxP Business Analyst & Project Manager

Location : Remote (Must be available during U.S. Eastern business hours)

Salary Range : $3500 - $5500 USD / month

Position Overview

We are seeking an experienced IT GxP Business Analyst & Project Manager to lead the alignment of evolving enterprise technologies with critical business strategies. This role is pivotal in translating complex Clinical Regulatory and Quality business needs into actionable systems and design specifications. It requires both strategic vision and hands-on project management, with a strong emphasis on regulatory compliance, process improvement, and cross-functional collaboration.

Key Responsibilities

1. Lead the design and implementation of IT projects following SDLC methodologies.
2. Facilitate requirements-gathering sessions across Clinical, Regulatory, Quality, and IT teams.
3. Analyze and improve business systems and workflows; identify compliance risks and process inefficiencies.
4. Translate business requirements into system specifications guiding software development, testing, and validation activities.
5. Implement governance processes ensuring GxP, GDPR, HIPAA, and SOX compliance.
6. Manage the full lifecycle of GxP-regulated projects: develop timelines, track deliverables, and ensure on-time delivery.
7. Provide clear, consistent communication and reporting across cross-functional stakeholders.
8. Monitor and address project risks proactively, managing issues to maintain momentum.
9. Promote a collaborative, accountable team culture.

Qualifications

• Education: Bachelor’s degree in a science-related or technical field.
• Experience: Strong background in GxP, Biopharma, Business Analysis & Project Management.
• Experience gathering and documenting requirements for practical implementation.
• Proficiency in ITIL-based service management and software development oversight.
• Familiarity with methodologies such as GAMP5, Agile, and Waterfall.
• Experience with Clinical systems (CTMS, EDC, eTMF, SCE) preferred.
• Experience with Quality systems (QMS, QDocs) preferred.
• Availability to work aligned with U.S. Eastern Time Zone.

Certifications (preferred but not required): PMP, ITIL, PRINCE2

Key Skills

Employment Type : Full Time

Experience : [Specify years of experience]

Vacancy : 1

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Project Manager • Johannesburg, Gauteng, South Africa