Senior Clinical Trial Specialist

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

Nusantara Prime Consulting Pte. Ltd (NPC)

is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.

Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.

Our Mission

With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.

Our Vision

To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.