Oncology Clinical Operations Manager

2 weeks ago

San Diego, California, United States Vertex Ventures HC Full time
Oncology Clinical Operations Manager

Vertex Ventures HC is a pioneering clinical-stage oncology organization committed to developing innovative therapies for patients facing challenging oncogene amplified cancers.

We are in search of a dedicated and skilled Oncology Clinical Operations Manager who will play a vital role in our clinical operations team, particularly contributing to our ongoing projects.

Key Responsibilities:
  • Collaborate with Contract Research Organizations (CROs) to provide expert guidance and daily management of global oncology clinical trials.
  • Track the progress of clinical trials, including patient enrollment, inventory of clinical trial materials, and reporting for executive leadership.
  • Assist in drafting and reviewing essential documents such as protocols, consent forms, and regulatory submissions.
  • Engage in the selection and qualification process for study sites and vendors.
  • Oversee vendors managed by Vertex, including financial tracking, timeline management, and documentation of oversight activities.
  • Contribute to the development and testing of validated electronic systems used in clinical trials.
  • Manage the operational aspects of study samples and drug supplies at clinical sites.
  • Support accrual management for ongoing studies and collaborate with the Clinical Operations team.
  • Coordinate with legal teams on outstanding matters related to contracts and agreements.
  • Work closely with cross-functional teams to ensure effective execution of studies, aligning vendor strategies with business objectives.
  • Provide administrative support for Clinical Supply Partnerships and present study updates during operational meetings.

All responsibilities will be executed in alignment with the company's core values and applicable regulations.

Qualifications:
  • Bachelor's degree in a scientific or health-related discipline or equivalent experience.
  • A minimum of 5 years of experience in clinical research support or a related field.
  • Strong analytical and problem-solving skills with the ability to foresee and address challenges.
  • Exceptional organizational skills and meticulous attention to detail.
  • Comprehensive understanding of the clinical drug development process, ICH, GCP guidelines, and US FDA regulations.
  • Excellent communication and interpersonal skills, fostering relationships both internally and externally.
  • A collaborative mindset with an appreciation for diverse perspectives.
  • A patient-centered approach to research.
  • Ability to thrive in a dynamic and fast-paced environment.
  • Proficiency in Microsoft Office and standard PC applications.
  • Willingness to travel up to 20% as needed.

The anticipated salary range for this position is competitive and commensurate with experience, including eligibility for an annual bonus and equity stock options.

Vertex Ventures HC offers a comprehensive benefits package, including medical, dental, vision, and life insurance for employees and their families, along with a flexible time-off policy.

We are committed to fostering an inclusive culture that values diverse backgrounds and experiences. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories.

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