Clinical Trial Manager, Oncology, Asia

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 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.

Position

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.

This position requires p roficiency 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 You

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.

What You’ll Do

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 (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

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

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 o…