Senior Clinical Trial Specialist CTR & CTA Expert (EU)

ORION PROJECT SERVICES PTE. LTD.; Singapore; Presencial; SGD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Orion Group Life Sciences is seeking a Senior Clinical Trial Specialist for a multinational biopharmaceutical client in Tuas, Singapore. This 12-month contract role focuses on managing CTAs, regulatory submissions, and trial-related regulatory activities across regions.

You will advise on submission strategies, oversee CTR compliance, and support inspection readiness while coordinating with cross-functional teams. Fluency in English and strong communication are essential.

Formación

• CTA experience required, preferably global submissions.
• Strong knowledge of EU CTR submission processes.
• Bachelor’s in Life Sciences; advanced degree preferred.
• Experience in a complex matrix organisation and regulatory databases.
• Excellent written and verbal communication and presentation skills in English.

Responsabilidades

• Manage a portfolio of CTAs including submissions and maintenance.
• Provide advice on submission strategies and country requirements.
• Act as SME on EU CTR submissions and guide cross-functional teams.
• Define CTR transition and submission strategies with stakeholders.
• Lead CTA-specific scientific advice procedures for study teams and management.
• Review CTR submission documents (Investigator's Brochures, protocols).
• Ensure CTA processes adhere to timelines and monitor milestones.
• Support inspection readiness and monitor regulatory developments.
• Maintain regulatory databases and trackers for reporting timelines.
• Provide operational support to the CTS team and regulatory systems.

Conocimientos

CTA experience

EU CTR knowledge

Regulatory submissions

Cross-cultural collaboration

Stakeholder management

English fluency

Project coordination

Attention to detail

Educación

Bachelor’s degree in Life Sciences

Advanced degree preferred

Herramientas

MS Word

Excel

PowerPoint

Adobe Acrobat

Regulatory databases

Descripción del empleo

Orion Group Life Sciences is seeking a Senior Clinical Trial Specialist for a multinational biopharmaceutical client in Tuas, Singapore. This 12-month contract role focuses on managing CTAs, regulatory submissions, and trial-related regulatory activities across regions.

You will advise on submission strategies, oversee CTR compliance, and support inspection readiness while coordinating with cross-functional teams. Fluency in English and strong communication are essential.