Clinical Trial Manager, Oncology, EMEA

$139,000 - $152,000/Yr

Eikon Therapeutics - Hayward, CA

Full-time - Mid Level

Hayward, CA

Professional, Scientific, and Technical Services

About the position

Eikon Therapeutics is seeking a talented, experienced, and highly motivated Clinical Trial Manager (CTM) to join our oncology Clinical Operations team. This role is critical in ensuring effective management of clinical trials, requiring onsite presence a minimum of 3 days a week in one of our California, New York, or New Jersey offices. The CTM will play a key role in contributing to high-quality in-house clinical study management, ensuring compliance with regulatory guidelines, and contributing to the planning, management, and successful completion of global clinical studies. The ideal candidate will possess strong communication skills, be a collaborative and agile trial leader with global trial experience, and have a passion for operational excellence and advancing patient care for grievous diseases. In this position, you will provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, delivering high-quality study data on time and on budget. You will develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials, collaborating with cross-functional teams, including data management, clinical scientists, regulatory, and investigators, to ensure operational excellence and rapid delivery of high-quality data. You will manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation. Additionally, you will monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines.

Responsibilities

• Provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials.
• Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials.
• Collaborate with cross-functional teams 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.
• Collaborate with other Clinical Operations functions to efficiently deliver study site initiation, training, and monitoring activities.
• 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.
• Ensure compliance with regulatory requirements throughout the trial lifecycle.
• Collaborate with external vendors to ensure their efficient and effective deliverables to the trial.
• Contribute to the development and review of study-related documents, such as protocols and informed consent forms.
• 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.

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.
• 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.
• 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 and related medical terminology.
• Ability to work onsite at least 3 days a week.
• Proficient in one European language and fluent in English.

Nice-to-haves

• Experience with global clinical trials in oncology.
• Familiarity with advanced clinical trial management software.
• Experience in vendor management and collaboration with CROs.

Benefits

• 401k plan with company matching
• Medical, 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%)
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site