Clinical Trial Manager, Oncology, Asia

Overview

Eikon 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 enables real time, molecular-resolution measurements of protein movement in living cells, unlocking otherwise intractable classes of proteins as drug targets.

We 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.

You 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.

• In 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 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. 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 documentation
• Collaborate with other Clinical Operations functions to 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 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
• Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle
• As required, 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

• 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…