Senior Clinical Operations Manager

1 week ago

Santa Clara, California, United States Bayside Solutions Full time

Position: Clinical Trial Manager / Senior Clinical Trial Manager

Employment Type: W2 Contract-to-Hire

Compensation: $156,000 - $187,200 annually

Work Arrangement: Hybrid or Remote

Overview:

This position presents a distinctive opportunity for a seasoned Clinical Operations Professional with substantial expertise in overseeing Phase I-III clinical trials within a corporate environment. The ideal candidate will possess a robust understanding of clinical operations, Good Clinical Practice (GCP), and regulatory standards set forth by the US Food and Drug Administration (FDA). As a Clinical Program Manager, you will be tasked with the oversight of Contract Research Organizations (CROs) and the successful execution of clinical studies.

Key Responsibilities:

  • Conduct clinical operations activities pertinent to the execution of assigned clinical trials, aligning with departmental and corporate objectives.
  • Oversee clinical studies and vendor relationships to ensure timely completion, adherence to budget, and compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP guidelines.
  • Identify, engage, and manage the activities of clinical CROs and other study providers to facilitate clinical trial execution.
  • Review and contribute to the development of study-specific documentation, including clinical trial protocols, case report forms, and informed consent forms.
  • Evaluate monitoring reports and other study documentation as necessary.
  • Supervise the collection and management of clinical trial documentation for the Trial Master File (TMF).
  • Participate in team meetings and collaborate with various functional groups within the organization to achieve clinical study objectives.
  • Track assigned team action items and proactively identify, escalate, and resolve issues as required.
  • Work with contract specialists to review and negotiate clinical trial agreements and site-specific budgets.
  • Assess the feasibility of potential clinical investigators and sites, evaluating facilities, personnel, and adherence to GCP.
  • Develop clinical study monitoring priorities and plans in collaboration with CROs.
  • Conduct site visits as necessary, including training and monitoring visits.
  • Manage investigational product accountability and reconciliation processes.
  • Assist in preparing safety, interim, and final clinical study reports while addressing data discrepancies.
  • Provide mentorship and guidance to Clinical Research Associates (CRAs) involved in clinical studies.
  • Prepare and monitor study participant enrollment projections against actuals and study budgets.
  • Act as the primary clinical operations contact for internal and external teams involved in assigned studies.

Qualifications:

  • BS or MS degree with a minimum of 5+ years of clinical operations experience in the pharmaceutical or biotech sector, ideally with a focus on Oncology drug development.
  • Hands-on experience managing early-stage clinical trials in an industry context.
  • Strong knowledge of FDA Regulations, ICH Guidelines, and GCPs governing clinical trial conduct.
  • Experience in selecting and managing CROs and external resources.
  • Proven track record of effective vendor management and teamwork.
  • Direct experience overseeing clinical CROs.
  • Ability to thrive in a collaborative team environment and a passion for deploying innovative approaches and technologies.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to manage multiple tasks, prioritize effectively, anticipate challenges, and achieve goals as part of an interdisciplinary team.
  • Willingness to travel as needed.
  • Oncology experience is preferred.
  • Experience with cooperative group studies and investigator-sponsored trials is advantageous.
  • Experience in global clinical trial operations is a plus.
  • Knowledge of APAC regulations is highly desirable.

Desired Skills:

Clinical trial management, Phase I-III studies, drug development, Oncology, GCP, FDA, ICH, vendor management, travel, APAC regulations.

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