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Clinical Trial Operations Manager

2 months ago

Reston, Virginia, United States Bayside Solutions Full time
Clinical Trial Manager Job Summary

This is a unique opportunity for an experienced Clinical Operations Professional with technical expertise in managing Phase I-III clinical trials in an industry setting and who has a strong knowledge of clinical operations, Good Clinical Practice (GCP), and US Food and Drug Administration (FDA) regulatory requirements.

Key Responsibilities:

  • Manage clinical studies and vendors to ensure studies are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and International Council for Harmonization (ICH)/ GCP guidelines.
  • Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) providers, and independent contractors) to execute clinical trials.
  • Review and contribute to developing study-specific documentation, including clinical trial protocols, case report forms, study guides/manuals, informed consent forms, and clinical databases.
  • Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
  • Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.

Requirements and Qualifications:

  • BS or MS degree with a minimum of 5+ years of clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in Oncology drug development.
  • Hands-on experience in running early-stage clinical trials within an industry environment.
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
  • Experience in the selection of CROs and vendors and management of external resources.
  • A demonstrable record of solid vendor management and teamwork.
  • Direct experience in managing clinical CROs.
  • Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is crucial.
  • Able to travel (~25%).
  • Oncology experience is preferred.
  • Experience in working with cooperative group studies and investigator-sponsored trials is preferred.
  • Experience in global clinical trial operations is a plus.
  • Knowledge of APAC regulations is highly desired.

About Bayside Solutions

Bayside Solutions, Inc. is a leading provider of clinical trial management services. We are committed to delivering high-quality solutions that meet the evolving needs of the pharmaceutical and biotech industries.