Lead Clinical Trial Management Specialist

1 week ago

California, United States Meet Full time

Position: Senior Oncology Study Management Specialist

Location: South San Francisco, CA (Onsite 3 days per week)

Our organization is a pioneer in oncology, dedicated to enhancing cancer treatment and patient care. With a passionate team engaged in innovative research, we aim to introduce transformative therapies to the market. As we broaden our initiatives and continue to make strides in oncology, we are in search of a skilled and seasoned Senior Oncology Study Management Specialist to become part of our vibrant team.

Primary Responsibilities:

  • Trial Oversight: Collaborate with the Clinical Trial Manager to supervise and manage all facets of clinical trials, encompassing study planning, execution, and closure. Ensure compliance with study protocols, regulatory mandates, and organizational standards.
  • Oncology Knowledge: Leverage your extensive expertise in oncology to assist in study design, patient recruitment, and data evaluation. Work alongside cross-functional teams to tackle oncology-specific challenges.
  • Regulatory Adherence: Guarantee that all clinical operations align with FDA regulations, ICH-GCP guidelines, and other pertinent standards. Prepare and review regulatory documents, submissions, and reports.
  • Vendor and Site Coordination: Liaise with external vendors and clinical sites to ensure prompt and precise execution of study activities. Address any challenges that arise and facilitate effective communication.
  • Data Oversight: Manage data collection, entry, and validation processes. Ensure data integrity and accuracy throughout the study lifecycle.
  • Collaborative Efforts: Partner closely with project managers, clinical research associates, and other team members to ensure alignment and effective execution of study objectives.

Required Qualifications:

  • A minimum of 5 years of experience in clinical study management with a strong focus on oncology studies.
  • Bachelor's degree in life sciences, nursing, or a related discipline. An advanced degree or certification (e.g., Clinical Research Coordinator or Clinical Research Associate) is advantageous.
  • Ability to work onsite 3 days per week in South San Francisco. Flexibility to accommodate project requirements and occasional travel as necessary.

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