Senior Clinical Program Manager, Clinical Operations Study Management

$170,800 - $187,200/Yr

Eikon Therapeutics - Hayward, CA

Full-time - Senior

Hayward, CA

Professional, Scientific, and Technical Services

About the position

The Senior Clinical Program Manager, Clinical Operations Study Management at Eikon Therapeutics is responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas. This role emphasizes operational excellence and high-performance delivery of clinical studies, requiring a minimum of three days a week of onsite presence in California, New York, or New Jersey. The successful candidate will collaborate with cross-functional teams to ensure studies are completed within timelines and budgets, focusing on quality and compliance.

Responsibilities

• Manage trial deliverables and timelines in assigned protocols to meet country commitments.
• Ensure quality and compliance in assigned protocols.
• Collaborate with Clinical Operations teams and Clinical Research and Development functional teams with minimal oversight.
• Work with finance, legal, external vendors, and clinical sites to ensure country deliverables are obtained for submissions, budgets, and regulatory milestones.
• Align with Regulatory and Clinical Operations on country timelines.
• Provide support and oversight to local vendors as applicable.
• Oversee local processes, clinical and ancillary supplies management, and archiving and retention requirements.
• Enter and update country information in clinical, regulatory, safety, and finance systems.
• Contribute or lead initiatives and projects adding value to the enterprise.
• Ensure clinical studies are conducted in accordance with approved protocols and relevant regulations.

Requirements

• 8+ years of experience with a Bachelor's degree, or 6+ years with a post graduate degree.
• In-depth knowledge of ICH-GCP, EMEA guidelines, and other relevant regulations.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards.
• Ability to develop risk management and mitigation plans and resolve issues locally.
• Effective time management, organizational, and interpersonal skills.
• Strong communication and negotiation skills, with excellent influencing and mentoring abilities.
• Ability to manage multiple deliverables and protocols simultaneously.
• Positive and growth mindset, capable of working independently.

Nice-to-haves

• Experience in oncology clinical trials.
• Familiarity with advanced clinical trial management systems.

Benefits

• 401k plan with company matching
• Medical, dental, and vision insurance (premiums covered by Eikon at 95% and 100% respectively)
• 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