We are seeking curious and committed individuals who are ready for the opportunity to transform how people living with cancer are treated. Our team is relentless in its focus to offer new hope to families facing devastating diagnoses. We value collaboration, inclusivity, and respect in how we engage with one another, working together to overcome challenges. We are building an exciting and fast-paced company that is passionate about discovering and developing tomorrow’s most innovative cancer therapies.

Salary Range: US$ 120K - 130K

Job Summary

The Senior Study Management Associate (Sr. SMA) / Study Management Associate (SMA), Clinical Operations, will report to the Head of Clinical Operations and be responsible for assisting in the oversight and management of clinical trial execution. The Sr. SMA/SMA will maintain oversight over CROs and key study CSPs to ensure quality conduct of trials and data collection, working closely with study sites and investigators. This role will also collaborate cross-functionally with departments such as Clinical Development, CMC/Supply Chain, Regulatory Affairs, and Project Management.

Principal Responsibilities

• Assist in managing all aspects of clinical trials to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
• Support the management of key study parameters (e.g., start-up activities, enrollment, site management, data collection, data reviews) and proactively address challenges within the clinical team.
• Develop and review informed consent forms, case report forms, study manuals, and other clinical trial materials.
• Assist with evaluating, selecting, and managing clinical study sites.
• Evaluate and manage CROs and other vendors; negotiate and manage contracts/budgets with CROs and vendors.
• Provide input to and manage project objectives to meet timelines and deliverables.
• Provide routine study updates to the cross-functional operations team.
• Develop action plans to address issues with investigational sites and/or CROs.
• Assist with the creation of study-specific tools and manuals to ensure timeliness, standardization, and control of data quality.
• Train new team members on study processes, as required.
• Track and maintain study metrics/progress and update the team regularly.
• Serve as the primary sponsor contact for sites.
• Participate in the analysis and reporting of safety issues, patient care issues, and study design or conduct issues.
• Review and negotiate clinical site study contracts and budgets.
• Plan, coordinate, and present at investigator meetings and CRO training meetings as requested.
• Participate in site qualification, initiation, interim monitoring, and close-out visits as needed; perform sponsor oversight visits to evaluate CRO site monitors.
• Support internal and regulatory audits of clinical trial sites and vendors, assisting with the resolution of audit findings.

Qualifications, Education & Experience

• Bachelor’s degree in a scientific discipline or health-related field.
• Minimum of 2 years of experience as a CRA in a biopharmaceutical company or CRO.
• Previous experience with oncology clinical trials is strongly preferred.
• Experience working on early development trials is a strong plus.
• Radiopharmaceutical expertise is a definite plus