Senior Clinical Operations Manager

1 week ago

Santa Clara, California, United States Bayside Solutions Full time

Position Title: 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 remarkable opportunity for a seasoned Clinical Operations Professional with substantial expertise in overseeing Phase I-III clinical trials within a corporate framework. The ideal candidate will possess a robust understanding of clinical operations, Good Clinical Practice (GCP), and the regulatory standards set forth by the US Food and Drug Administration (FDA). As a Clinical Program Manager, your primary responsibilities will include managing Contract Research Organizations (CROs) and ensuring the successful execution of clinical studies.

Key Responsibilities:

  • Execute clinical operations tasks related to the management of assigned clinical trials in alignment with departmental and organizational objectives.
  • Oversee clinical studies and vendor activities to guarantee timely completion, budget adherence, and compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP guidelines.
  • Identify, engage, and supervise the functions of clinical CROs and other study providers (e.g., core laboratories, Electronic Data Capture (EDC) vendors, and independent contractors) to facilitate clinical trials.
  • Review and assist in the creation of study-specific documents, including clinical trial protocols, case report forms, study manuals, informed consent documents, and clinical databases.
  • Examine monitoring reports and other study-related documentation as necessary.
  • Manage the collection and organization of clinical trial documentation for inclusion in the Trial Master File (TMF).
  • Participate in team discussions and collaborate with various functional departments within the organization (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory Affairs, Quality Assurance, Finance, Legal) to meet clinical study objectives.
  • Follow up on assigned team action items, and identify, escalate, and resolve issues as they arise.
  • Work alongside contract specialists to review and negotiate clinical trial agreements and site-specific budgets.
  • Evaluate the suitability and feasibility of potential clinical investigators and sites, including assessing facilities, personnel, patient referral networks, and compliance with GCP.
  • Develop clinical study monitoring priorities and Monitoring Plans in collaboration with CROs.
  • Conduct site visits (e.g., training, initiation, monitoring) as required.
  • Oversee investigational product accountability and manage the reconciliation process.
  • Assist in preparing safety, interim, and final clinical study reports, as well as resolving data discrepancies.
  • Provide mentorship, leadership, and guidance to Clinical Research Associates (CRAs) assigned to 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:

  • Bachelor's or Master's degree with a minimum of 5+ years of clinical operations experience in the pharmaceutical or biotechnology sector, preferably with a focus on Oncology drug development.
  • Hands-on experience managing early-stage clinical trials in an industry context.
  • Comprehensive 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 in managing clinical CROs.
  • Ability to thrive in a collaborative team environment and a strong desire to implement innovative approaches and technologies in a dynamic setting.
  • Exceptional written and verbal communication skills.
  • Demonstrated capacity to manage multiple tasks, prioritize effectively, anticipate challenges, and achieve goals as part of an interdisciplinary team.
  • Willingness to travel (~25%).
  • 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, drug development, Oncology, GCP, FDA, ICH, vendor oversight, travel, APAC regulations.

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