Senior Clinical Trial Specialist - SGP

one stop engineering pte. ltd.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

one stop engineering pte. ltd. is seeking an experienced CTA regulatory submissions professional to manage a portfolio of CTAs, ensure timely submissions, and provide strategic guidance on country requirements.

You will train and advise cross-functional teams, lead CTR-related processes, and maintain high-quality regulatory documentation. The role requires a Bachelor’s degree in life sciences with 6–7 years CTA experience, strong IT skills, and excellent communication in English.

Qualifications

• Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences.
• 6–7 years CTA experience, preferably in global clinical trial submissions to regulatory agencies.
• Proficient IT skills: MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.

Responsibilities

• Manage a portfolio of CTAs including preparation and distribution of documentation for new CTAs and maintenance activities.
• Provide advice on submission strategy and country requirements for regulatory submissions.
• Act as SME on EU CTR submissions, guiding cross functional teams and defining submission strategies.

Skills

Regulatory submissions

Cross-cultural collaboration

Communication

Independent working

Project coordination

Education

Bachelor's degree in life sciences

Advanced life sciences degree preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat

Global databases

Job description

Description:

Major Responsibilities

• Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc.
• Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
• SME on all aspects of EU CTR submissions including platform and complex trials, guiding cross functional teams through the process and providing training and education on the processes. Define strategy for CTR transitions and initial submission alongside other key stakeholders. Modify processes and strategy based on lessons learned.
• Lead CTA specific scientific advice procedures, including advising study teams and management of the different options and leading strategies on when to utilize
• Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
• Ensure approved company CTA processes are followed within agreed timelines.
• Good understanding of CTR process and requirements.
• Monitor key project milestones (actual vs. planned activities and timelines) and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures.
• Support inspection readiness activities when applicable
• Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
• Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
• Provide technical support on document preparation e.g. Excel spreadsheets, Power Point presentations.
• Undertake all necessary training in order to achieve compliance with internal/external processes
• Provide operational support for the CTS Team as required.
• Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.
• This position reports to the Associate Director, CTS

Education

Required: Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.

Preferred: Relevant advanced degree in life sciences is preferred

Experience

• At least 6-7 years CTA experience, preferably in global clinical trial submissions to regulatory agencies.
• Experience working effectively across cultures and in a complex matrix environment
• Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.
• Proactive verbal and written communication style at all levels.
• Solution driven style.
• Shows high level of initiative and ability to work independently
• Has excellent communication/presentation skills, written and verbal; fluency in English.
• Strong proven personal development and motivational skills.
• Strong interpersonal, organisational and team working skills.
• Ability to establish and maintain excellent working relationships with primary interfaces located at remote geographical sites