Senior Clinical Trial Specialist

Nusantara Prime Consulting Pte. Ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Nusantara Prime Consulting Pte. Ltd. is seeking an experienced CTA regulatory professional in Singapore to manage CTAs, support regulatory submissions, and guide cross-functional teams through CTR processes.

The role requires strong IT skills, excellent communication, and the ability to work independently in a multicultural, matrix environment. 12-month contract with opportunities for training and process optimization.

Qualifications

• Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences is required.
• Relevant advanced degree in life sciences is preferred.

Responsibilities

• Manage a portfolio of CTAs including preparation and distribution of documentation for new CTAs and all CTA maintenance activities.
• Provide advice on submission strategy and country requirements, plus operational support for regulatory submissions and amendments.
• SME on EU CTR submissions including platform and complex trials, guiding cross-functional teams and training on processes.

Skills

Regulatory submissions

Cross-cultural teamwork

Information Technology

Communication skills

Initiative

Independent work

Education

Bachelor's degree in life sciences

Advanced life sciences degree preferred

Tools

MS Word

MS Excel

PowerPoint

Adobe Acrobat

Global databases

Job description

Job 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 the company.

Requirements:

• Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
• Relevant advanced degree in life sciences is preferred
• 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

Contract Duration: 12 months