Eikontherapeutics
Clinical Trial Manager, Oncology, Asia
Jersey City, NJ; Millbrae, CA
Sponsorship not specifiedDetected 2 days ago
GCPProject ManagementClinical TrialsPatient CareFDA RegulatoryResearchCommunicationProblem Solving
About the role
- 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.
- 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.
- 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.
Responsibilities
- 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
- 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)
- 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
- 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
- Proficiency in using Veeva clinical trial management systems (CTMS)
- As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial
- Proven experience in Clinical Operations; Oncology trial management experience preferred
- 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
- 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
- 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
Nice to have
- Proven experience in Clinical Operations
- Oncology trial management experience preferred
Compensation
- At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
Benefits
- Generous paid time off and holiday policies
Visa & Work Authorization
- Lead periodic review of the Sponsor Trial Master File
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