Clinical Trial Associate at Novartis

, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

24 Sep, 26

Salary

0.0

Posted On

26 Jun, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Clinical Trials, Lifesciences, Partner Relationship Management (PRM), Project Planning, Waterfall Model

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary The Clinical Trial Associate (CTA) supports SSO Study Start-Up Manager, Study Start-up CRA and Clinical Research Associate in assigned studies during set-up and whole study lifecycle in compliance with Novartis processes, GCP/ICH and regulatory requirements. Job Description Key Responsibilities Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and Novartis requirements; document oversight and tracking Supports Vendor set-up as applicable Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s) Supports preparation and translation of ICF into local languages (including vendor management if necessary) Responsible for completeness of uploaded trial related documents into Trial Master File, including archiving of paper TMFs Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements Provides logistic support to SSU CRA, CRA, CPM, SSU Manager in all phases of the clinical trial Implements innovative and efficient processes which are in line with Novartis strategy Essential Requirements: Degree or equivalent in a scientific, medical, or related field, with prior exposure to clinical operations (preferably ≥1 year). Basic knowledge of clinical drug development, particularly study start-up, submissions, and contracting workflows. Demonstrates understanding of ICH/GCP, IRB/IEC, and Health Authority requirements, ensuring compliance in daily activities. Supports preparation, collection, tracking, and maintenance of regulatory documents and TMF to ensure completeness and audit readiness. Able to support IRB/EC and Health Authority submissions, including document preparation and adaptation. Proficient in maintaining study systems (e.g., document repositories, tracking systems) and ensuring timely and complete uploads Skills Desired Clinical Research, Clinical Trials, Lifesciences (Inactive), Partner Relationship Management (PRM), Project Planning, Waterfall Model Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

The Clinical Trial Associate supports the study start-up and lifecycle by managing document collection, TMF maintenance, and regulatory submissions. They ensure compliance with GCP/ICH and Novartis processes while coordinating with vendors and internal stakeholders.