Clinical Project Manager

4 days ago

Singapore AXCYNSIS THERAPEUTICS PTE. LTD. Full time

Axcynsis Therapeutics is seeking a highly motivated **Clinical Project Manager (CPM)**with hands-on experience managing clinical trials in the United States, preferably in **Oncology and Antibody Drug Conjugates (ADCs)**. You will be responsible for overseeing all aspects of clinical trial execution including trial planning, vendor and site management, stakeholder coordination, and regulatory compliance.

**Key Responsibilities**:

- Lead and coordinate cross-functional teams to ensure timely and on-budget delivery of trial milestones.
- Prepare, review, and maintain essential clinical trial documents (Investigator Brochure, Protocol, ICFs, and Trial Master File).
- Manage the IRB/EC approval process across all trial sites.
- Lead clinical budget planning, contract negotiations, and financial oversight of CROs, vendors, and sites.
- Oversee selection, qualification, and ongoing performance of clinical vendors and investigative sites.
- Coordinate Investigational Product (IP) labeling, packaging, distribution, and ongoing supply logistics.
- Manage biological sample logistics, ensuring proper handling, shipment, and storage.
- Foster strong working relationships with clinical sites to support protocol compliance and patient recruitment.
- Serve as the central communication point for internal development teams, external partners, and KOLs.

**Qualifications**:

- BSc, MSc or PhD in life sciences or a related field;
- Minimum 2 years of clinical project management experience.
- Proven track record in managing early-phase (especially Phase 1) U.S.based clinical trials.
- Prior experience in oncology trials is essential; ADC experience is a strong advantage.
- Strong vendor and site management capabilities.
- Solid understanding of FDA regulations, IND requirements, and ICH-GCP guidelines.
- Proficient with TMF systems, CTMS, and other relevant clinical trial platforms.
- Excellent leadership, interpersonal, and problem-solving skills.
- Axcynsis Therapeutics is an equal opportunity employer and all qualified applicants will receive consideration for employment._

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