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. The successful candidate will play a critical role in assisting the development of our eTMF system, SOP maintenance roll out within clinical operations and assist with some site management responsibilities.
Key Responsibilities:
Quality Site Execution
- Assist with the collation and execution of SOP Rollout and training where applicable.
- Ensure Clinical Operations Team Member training compliance and understanding
- Assist with Clinical site Inspection Readiness for clinical studies conducted under the banner of Axcynsis Therapeutics Pte Ltd (either as direct project and monitoring or as oversight for outsourced studies)
- Assist Clinical Operations team with preparation and conduct of QC tasks as cited in QC Plan
- Assist with ongoing reflection of issues noted as part of audit finding(s) or incident findings during routine inspection readiness review and or at co-monitoring visit
- Assist with the review, generation and or modification of current or new SOP(s) as required.
eTMF(Subject Matter Expert)
- Assist with the maintenance of eTMF system
- Assist with the upload of documents into the eTMF(real time).
- Prepare summary of inspection readiness and eTMF file readiness monthly
Site Management
- Be(CRA) backup point of contact for site during the entire study execution
- Assist with Site Data Review of EDC.
- Assist with Site Data Verification as applicable and required.
- Assist with conduct site initiation visits (if required), participate in training of site staffs with the study specific elements
- Assist CRA with regular site visits and close out visits as designed by Study Project Manager (PM)
Other duties as required
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. Ability to work both independently and collaboratively within a dynamic biotech startup environment
To apply for this role, please email [Confidential Information]
Axcynsis Therapeutics is an equal opportunity employer and all qualified applicants will receive consideration for employment.
