Clinical Trial Manager, Oncology, Asia

About the role

Eikon Therapeutics is seeking a Clinical Trial Manager (CTM) to join our oncology Clinical Operations team. This role requires onsite presence a minimum of 3 days a week in our Millbrae, CA or Jersey City, NJ office. The candidate must have strong Mandarin, Cantonese, Japanese, or Korean language skills and proficiency in English.

Responsibilities

• Provide guidance and daily oversight for the successful in-house management of all aspects of international in-sourced clinical trials, delivering high quality study data, on time and on budget
• Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials
• Collaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data
• Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention
• Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines
• Absolutely ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle
• Collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial
• Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs)
• Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements
• Lead the creation and maintenance of all study files, including the study master file, and oversight of site files
• Lead periodic review of the Sponsor Trial Master File

Requirements

• PhD and 3 years of relevant experience, or Masters Degree and 6 years of relevant experience, or Bachelors Degree and 8 years of relevant experience
• Proven experience in Clinical Operations; Oncology trial management experience preferred
• In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research
• Demonstrated experience in managing and executing clinical trials from start-up to closeout
• Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary
• Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations
• Proficiency in using Veeva clinical trial management systems (CTMS)
• Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology

Qualifications

• PhD and 3 years of relevant experience, or Masters Degree and 6 years of relevant experience, or Bachelors Degree and 8 years of relevant experience
• Proven experience in Clinical Operations; Oncology trial management experience preferred
• In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research
• Demonstrated experience in managing and executing clinical trials from start-up to closeout
• Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary
• Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations
• Proficiency in using Veeva clinical trial management systems (CTMS)
• Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology

Skills

• Strong communication skills
• Collaborative, agile, detail oriented trial leader
• Passion for operational excellence and advancing patient care for grievous diseases

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

Pay

The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.

Schedule

This role requires onsite presence a minimum of 3 days a week in our Millbrae, CA or Jersey City, NJ office.