Regional Clinical Operations Specialist (Sponsor-Side, 12-Month Contract)

We are a growing biotech company seeking a highly skilled Clinical Operations Specialist to manage the end-to-end operational, financial, and clinical execution of studies across Southeast Asia.

This role is ideal for a detail-oriented Clinical Research Associate (CRA) with 2–4 years of monitoring experience who is ready to step into a sponsor-side position with significant responsibility in:

• Regional study management – coordinating CROs, sites, and cross-functional teams to ensure studies are delivered on time, on budget, and in compliance with regulations
• Financial operations & procurement – managing site payments, POs, invoices, accruals, and vendor interactions
• Data oversight – performing data review, query management, and data cleaning
• Contract coordination – supporting site agreements, payment milestones, and liaising with legal teams
• CRA responsibilities as needed – including site due diligence visits and operational oversight

This position offers a unique opportunity to move beyond traditional monitoring, gaining exposure to the commercial, operational, and strategic aspects of sponsor-side clinical trials while contributing directly to a growing biotech's regional clinical programs.

Key Responsibilities

Regional Study Oversight

• Track study timelines, milestones, enrolment progress, and country-level deliverables

• Oversee CRO performance and ensure contractual deliverables are met

• Identify operational risks and support mitigation planning

• Support site start-up and activation planning across multiple countries

Financial Operations & Procurement Management

• Manage the full lifecycle of site payments across regional studies

• Generate and track purchase orders (POs) in alignment with approved study budgets

• Review, validate, and process site invoices and pass-through costs

• Ensure payments align with Clinical Trial Agreements (CTAs) and milestone structures

• Track accruals and maintain accurate financial records for study forecasting

• Respond to finance and procurement queries and reconcile discrepancies

• Monitor overall study financial status and escalate variances proactively

Data Review & Quality Oversight

• Perform ongoing clinical data review and data cleaning activities

• Identify data inconsistencies and follow up with sites and CROs for resolution

• Track and manage EDC queries to ensure data integrity

• Build and maintain eCRFs on the EDC for new studies

Contract & Site Agreement Support

• Support review and coordination of Clinical Trial Agreements (CTAs), site budgets and vendor (e.g. CROs) budgets

• Provide operational input on payment schedules and milestone structures

• Liaise with legal, regulatory, and finance teams during contract negotiation and finalization

• Track contract execution timelines to support timely site activation

Site & CRO Partnership

• Serve as a sponsor-side operational contact for sites and CRO partners

• Review monitoring reports and ensure timely resolution of action items

• Participate in selected site visits and investigator meetings (as required)

• Maintain strong collaborative relationships to drive study performance

Documentation & Compliance

• Maintain oversight of Trial Master File (TMF) completeness and quality

• Consolidate regional study updates for internal reporting

• Ensure study conduct aligns with ICH-GCP and applicable local regulations

• Support audit and inspection readiness activities

What We Are Looking For

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biomedical Science, or related field

• 2–4 years of CRA experience in clinical trials, preferably in a CRO setting and performed monitoring

• Strong understanding of site payment structures and CTA-linked milestones

• Exposure to invoice review, PO generation, or financial tracking processes preferred

• Hands-on experience with EDC systems and clinical data review

• Strong attention to detail and financial accuracy

• Excellent cross-functional communication skills

• Ability to work independently in a remote, regional environment

• Fluency in English; Mandarin/Chinese proficiency is an advantage

• Willingness to travel within Southeast Asia