Clinical Trial Manager

POSITION SUMMARY:

Reporting to the Head of Clinical Operations, the Clinical Trial Manager contributes to the clinical operations of BPGbio studies while working collaboratively with the CROs, third-party vendors, site investigators and research staff contracted by BPGbio. Manages the assigned clinical studies and ensures effective cross-functional teamwork among project team members both internal and external services.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage the conduct of assigned clinical trials. Develop tools for tracking and managing clinical budgets and timelines. Proactively identify issues and mitigate risks to ensure project deliverables are met according to industry standards

• Clinical site communication and management
• Vendor management, maintain vendor management tracking tools
• Work with vendor and clinical sites for drug supply management and tracking, and lab supplies and sample management and tracking

• Perform invoices review, approval, and tracking. Assist in negotiate & establish contracts and budgets with clinical sites and vendors

• Assist in the development, implementation, review/QC, and maintenance of Clinical Trial Master File

• Develop training programs for internal and external resources (lab manual / pharmacy manuals/ slides)

• Maintain study trackers and tools. Prepare meeting agendas and minutes as directed.
• Coordinate the scheduling of all trial-related conference calls
• Assist in the development, review, and distribution of study documents
• Participate in process improvement activities. Assist Clinical Operations in the creation and maintenance of internal policies and SOPs as well as policies intended to assist researchers in maintaining compliance with research standards and guidelines
• Work with study team in preparation for audits/inspections.
• Ensure adherence to study protocols and compliance with SOPs, GCP, ICH and regulatory guidelines
• Ensure adherence to protocols and compliance with GCP, ICH, GMP, and regulatory guidelines
• Other duties, as assigned.

QUALIFICATIONS:

• Requires a BS degree in a scientific discipline with a 5+ years of clinical research experience of Phase I-III clinical trials in the pharmaceutical industry and/or CRO, (or equivalent) with a strong preference for experience in oncology and rare diseases.
• Excellent MS Office applications skills, especially well-versed in the development and use of Excel spreadsheets. Attention to details
• Strong understanding of regulatory requirements
• Ability to communicate effectively with physicians, fellow employees, patients, contractors and vendors

• Experience and success working in a busy team environment under high pressure