Senior Clinical Trial Specialist
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.
Major Responsibilities
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.
Education & Experience
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.