Contract Clinical Trials Specialist (PHRMA/CLINICAL RESEARCH MNC) **IMMEDIATE**
Recruit Express Pte Ltd| Date Posted: 27-May-2020
EA Licence No: 99C4599|EA Personal Registration No: R1879124
Bachelor's / Honours, Masters / PhD
- 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 trials notifications etc.
- Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
- Review of and input on documents related to clinical trial submissions managed by other stakeholders
- Ensure approved company CTA processes are followed within agreed timelines.
- 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.
- 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 nonRegulatory systems that are critical for Regulatory submission and maintenance activities.
- Other duties as assigned
- Min Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject
- At least 2-years Regulatory Affairs or Clinical Trials experience.
- 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.
- Strong interpersonal, organisational and team working skills.
- Strong Project Management skills, able to manage multiple activities in line with business priorities and study time goals Able to start work immediately or on short notice
Interested candidate, kindly send a copy of your resume to: [Click Here to Email Your Resume]
Jessica Fong Zhi Tong
CEI Registration No.: R1879124
EA Licence No.: 99C4599
Recruit Express Pte Ltd