Clinical Trial Manager, Oncology, EMEA

$130,000 - $142,500/Yr

Eikon Therapeutics - Hayward, CA

Full-time - Mid Level

Hayward, CA

Professional, Scientific, and Technical Services

About the position

The Clinical Trial Manager (CTM) at Eikon Therapeutics will oversee the management of international oncology clinical trials, ensuring compliance with regulatory guidelines and contributing to the successful completion of global studies. This role requires a minimum of three days onsite presence in California, New York, or New Jersey, and involves collaboration with cross-functional teams to deliver high-quality study data on time and within budget.

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, including site selection and feasibility assessments.
• Collaborate with Clinical Operations functions to deliver study site initiation, training, and monitoring activities.
• Develop and maintain strong relationships with investigators and study site personnel to facilitate patient recruitment and retention.
• Monitor and evaluate study progress, identifying risks and implementing corrective actions.
• Ensure compliance with regulatory requirements throughout the trial lifecycle.
• Collaborate with external vendors to ensure efficient 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.
• Lead the creation and maintenance of all study files, including the study master file.

Requirements

• PhD with 3 years of relevant experience, or a Master's Degree with 6 years of relevant experience, or a Bachelor's Degree with 8 years of relevant experience.
• Proficiency in one European language and fluency in English.
• Proven experience in Clinical Operations, with a preference for oncology trial management experience.
• In-depth knowledge of clinical trial regulations, 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 prioritize tasks and manage study timelines and budgets.
• Excellent interpersonal and communication skills to collaborate effectively with stakeholders.
• Detail-oriented with strong analytical and problem-solving abilities.
• Proficiency in using Veeva clinical trial management systems (CTMS).
• Understanding of oncology therapeutic areas and related medical terminology.
• Ability to work onsite at least 3 days a week.

Benefits

• 401k plan with company matching
• Medical, dental, and vision insurance (premiums covered by Eikon at 95% and 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