Clinical Trial Manager, Oncology, Asia

Clinical Trial Manager, Oncology, AsiaEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.PositionWe are seeking a talented, experienced, and highly motivated Clinical Trial Manager (CTM) to join our oncology Clinical Operations team. This role will require onsite presence a minimum of 3 days a week in our Millbrae, CA or Jersey City, NJ office to ensure effective global clinical trial management. The candidate must have the ability to work independently, be an effective leader, and an engaged clinical study team member in a dynamic, fast-paced environment. You will play a key role in contributing to high quality in-house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and the successful completion of global clinical studies.This position requires proficiency in Mandarin, Cantonese, Japanese, or Korean and English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels).About YouYou have strong communication skills and are a collaborative, agile, detail oriented trial leader with global trial experience, and you have a passion for operational excellence and advancing patient care for grievous diseases.What You'll DoIn partnership with Clinical Study Management, 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 budgetDevelop and execute operational plans for the successful in-house implementation and management of oncology clinical trialsCollaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data. Ability to examine functional issues from a broader organizational perspective.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 documentationCollaborate 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 guidelinesCollaborate 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 retentionMonitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelinesEnsure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycleAs required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trialContribute 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 requirementsLead the creation and maintenance of all study files, including the study master file, and oversight of site filesLead periodic review of the Sponsor Trial Master FileQualificationsPhD and 3 years of relevant experience, or Masters Degree and 6 years of relevant experience, or Bachelors Degree and 8 years of relevant experienceProven experience in Clinical Operations; Oncology trial management experience preferredIn-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology researchDemonstrated experience in managing and executing clinical trials from start-up to closeoutStrong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgetsExcellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessaryDetail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviationsProficiency in using Veeva clinical trial management systems (CTMS)Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminologyAbility to work onsite at least 3 days a weekAt Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:401k plan with company matchingMedical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)Mental health and wellness benefitsWeeklong summer and winter holiday shutdownsGenerous paid time off and holiday policiesLife/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policiesEnhanced parental leave benefitDaily subsidized lunch program when on-siteThe expected salary range for this role is $130,000 to $157,500 depending on skills, competency, and the market demand for your expertise.Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.