Clinical Project Manager

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 / 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.

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