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Open nowPosted 7 days ago

Senior Clinical Trial Specialist

ORION PROJECT SERVICES PTE. LTD.

Pay
SGD 5,000 – SGD 6,000 a month
Where
West, Singapore
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Your applicationOpen nowSenior Clinical Trial SpecialistORION PROJECT SERVICES PTE. LTD. · West, Singapore

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.7%14 days
  5. 35.6%30 days
  6. 58.0%60 days
This job: posted 7 days ago

The posting

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.

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