Clinical Trial Project Manager

4 days ago

Singapore OASIS BIO PTE. LTD. Full time

**Oasis Bio Pte Ltd**is a growing pharmaceutical/biotech company dedicated to advancing innovative and affordable therapies to improve patient outcomes. We are looking for an experienced Clinical Trial Project Manager to lead and drive clinical studies from start-up through close-out in accordance with regulatory requirements, timelines, and budget.

**Key Responsibilities**
- Lead the planning, execution, and management of Phase I-IV clinical trials across multiple therapeutic areas including cell and gene therapy.
- Serve as the main point of contact for internal teams, CROs, vendors, and clinical sites.
- Develop and manage project timelines, risk mitigation plans, budgets, and resources.
- Oversee study start-up activities including site selection, feasibility assessments, and ethics/regulatory submissions.
- Monitor trial progress, track key milestones, and ensure compliance with ICH-GCP, regulatory guidelines, and SOPs.
- Support data management, safety reporting, and trial master file (TMF) maintenance.Provide regular project status updates to senior management and stakeholders.

**Qualifications**
- Bachelor's degree in Life Sciences, Medicine, Pharmacy, or related field ( **Advanced degree preferred**).
- 5+ years of experience in clinical trial operations, with at least 2 years in a project management role.
- Strong knowledge of ICH-GCP, FDA/EMA/HSA regulations, and clinical trial lifecycle.
- Experience working with CROs and cross-functional global teams.
- Excellent communication, organizational, and leadership skills.
- PMP or equivalent project management certification is a plus.

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