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.
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 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.
Ability to work onsite at least 3 days a week.
Proficient in Mandarin, Japanese, or Korean and English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels).
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
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
The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.