Clinical Trial Manager

Summary

The job is for a Clinical Trial Manager at Orca Bio, a biotech company specializing in cell therapies for blood cancer patients. The role involves managing early stage clinical studies and ensuring compliance with regulations and guidelines.

Requirements

• BA/BS or equivalent with 5+ years of relevant clinical trial management experience
• Therapeutic experience in oncology/hematology and cell and gene therapy preferred
• Prior experience with early stage clinical trials at a small biotech/life science company preferred
• Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
• Experience with Trial Master File management according to the DIA reference model
• Experience operating within various site EMR/EHR systems
• Experience using eTMF, EDC (IBM experience ideal) , CTMS, and other vendors systems/portals

Responsibilities

• Provide study-specific training and leadership to clinical research staff
• Assist with monitoring overall CRA, site and vendor performance and study progress as it relates to timelines, budgets, quality, and compliance with relevant regulations and guidelines
• Identify potential study issues, and ensure optimization of delivery of scoped services and internal resources
• Leverage operational and therapeutic expertise to optimize trial design and execution
• Determine, develop, and implement tracking and reporting specifications
• Work with the study team to design clinical protocol; provide input for the design of the ICF template, source documents and CRFs
• Prepare and/or review study-related documents to include clinical logs, forms, manuals, and guidelines
• Track and manage subject recruitment across study sites
• Oversee the management of study monitoring visits, and the review and approval of monitoring reports
• Mentor and develop in-house CRA team
• Monitor site performance on an ongoing basis and escalate any infringements, breaches, and misconduct, fraud, and negative trends
• Oversee ongoing protocol deviation tracking, reporting, and trending
• Oversee the collection, review and filing of site essential documents, and maintenance of the TMF
• Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies
• Participate in the planning of quality assurance activities, internal and external audits/inspections and assist with resolution of audit/inspection findings
• Assist with development and management of clinical budgets and contracts
• Collaborate with cross functional teams to create and implement study-specific tools (metrics reports, patient profiles) to ensure clean data

Preferred Qualifications

• Entrepreneurial and passionate; enjoys working in a fast-paced, collaborative environment
• Highly detail oriented with special attention to quality and quality control
• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
• Excellent problem resolution and organizational skills; desire to improve upon established processes
• Strong interpersonal skills, including verbal and written communication, and a sense of humor
• Ability to work independently and as part of a team
• Flexibility in responding to change or business needs

Benefits

• The anticipated annual salary range for this job will be based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law
• You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits
• Other perks include free daily lunches and snacks at our on-site locations