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 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.

To apply for this role, please email [email protected]

Axcynsis Therapeutics is an equal opportunity employer and all qualified applicants will receive consideration for employment.