Senior Clinical Trial Specialist

About the company

Orion Group Life Sciences are currently recruiting a Senior Clinical Trial Specialist on behalf of our multinational biopharmaceutical client based in Tuas, Singapore, on an initial 12-month contract with potential to extend.

Your tasks

• Manage a portfolio of Clinical Trial Applications (CTAs), including initial submissions, substantial amendments, end-of-trial notifications and ongoing maintenance activities.
• Provide advice on regulatory submission strategies, country-specific requirements and the preparation and processing of submissions and amendments.
• Act as a subject matter expert on EU Clinical Trials Regulation (CTR) submissions, including complex trials, providing guidance and training to cross-functional teams.
• Define strategies for CTR transitions and initial submissions alongside key stakeholders, incorporating lessons learned to improve processes.
• Lead CTA-specific scientific advice procedures, advising study teams and management on available options and appropriate strategies.
• Review and provide input on clinical trial submission documents, including Investigator's Brochures and protocols.
• Ensure approved CTA processes are followed within agreed timelines and monitor key project milestones, escalating issues or changes as required.
• Support inspection readiness activities and monitor regulatory developments relating to clinical trials.
• Maintain regulatory databases and activity trackers, ensuring compliance with reporting requirements and submission timelines.
• Provide operational and technical support to the Clinical Trial Strategy & Submissions (CTS) team, including regulatory systems and documentation.
• Ensure compliance with internal policies, procedures and applicable regulatory requirements.

Requirements

• Bachelor's degree in Medicine, Pharmacy, Biology, Chemistry, Pharmacology or a related Life Sciences discipline.
• Advanced degree in Life Sciences preferred.
• At least 4-5 years' experience in Clinical Trial Applications (CTAs), preferably involving global clinical trial submissions to regulatory agencies.
• Strong knowledge of EU CTR submission processes and regulatory requirements.
• Experience working across cultures within a complex matrix organisation.
• Proficiency in Microsoft Word, Excel, PowerPoint, Adobe Acrobat and regulatory databases.
• Excellent written and verbal communication and presentation skills, with fluency in English.
• Ability to work independently, demonstrate initiative and develop effective relationships with stakeholders across different geographical locations.
• Strong organisational, interpersonal, analytical and problem-solving skills.