Clinical Trial Manager

Redwood City, CA 94063

Posted: 06/11/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17560

Job Description


General Position Summary/Purpose:

The Clinical Trial Manager  is a critical within the clinical team that works on-site in the Redwood City office. In close collaboration with the  Study Director, the CTM  will work to manage and provide daily operational oversight of Contract Research Organization (CRO), study vendors, and clinical trial sites. The CTM  will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and in accordance with regulatory requirement, Good Clinical Practice (GCP) guidelines and company SOPs.

 

Key Accountabilities/Core Job Responsibilities:
  • Supports CTM and/or Study Director and cross-functional representatives as required in relationship management tasks (e.g. contracts, study logistics, patient enrollments, safety, data management, etc.) to accurately coordinate clinical study activities
  • Leads or participates in vendor management activities
  • Assists with the development of protocol, informed consent development, CRFs, tracking forms, and other study related documents
  • Independently manages the study start up activities for multi-center, US and/or global based studies
  • Provides monitoring oversight by reviewing monitoring schedules, metrics and reports
  • Develop collaborative partnership with clinical sites to ensure that all clinical sites adherence to protocol, trained on study procedures and complies to all applicable GCP/ICH guidelines, regulations statutes and SOPs
  • Performs in-house routine data listing review
  • Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Mentors and coach junior staff new to Clinical Research (e.g. Clinical Trial Assistant)
  • Assists with the development of protocol, informed consent development, CRFs, tracking forms, and other study related documents
  • Performs monitoring visits (feasibility, SIV, IMV, Close-out) or with CRO CRAs to assess the sites’ and CRA’ s overall performance, as needed
  • Performs other duties and assignments as required for overall success of the projects. Duties my change based on the status of clinical programs and ongoing needed of the organization

 

Qualifications & Skills:
  • Working knowledge of ICH/GCP and FDA guidelines
  • Effective verbal and written communication skills
  • Attention to detail and organizational skills
  • Ability to “ roll up your sleeves” and individually contribute results in a smaller organization to supports other assigned duties
  • Ophthalmology experience preferred but not required
  • Proficiency in MS Word, Excel and PowerPoint
  • Ability to travel up to 20%

 

Education Requirements (degree, certifications, etc.): 

BS/BA, RN, or equivalent with at least 4 years of clinical trial management and vendor management experience/ clinical trial monitoring

 

Meet Your Recruiter

Ron Tess

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