Clinical Trial Manager *PC

Your Role

The Clinical Trial Manager drives the clinical trial execution activities for assigned clinical trials, and ensures trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP, SOPs and business guidelines for Biomedicine, Inc.

• Provide input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials).
• Lead cross-functional trial execution team to ensure delivery of complex clinical trials and manages protocol execution.
• Identify and/or anticipate operational risks and mitigation plans within assigned clinical trials, and escalates issues and recommends contingency plans to Director of Clinical Operations as necessary.
• Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, update of trial information in all trial databases and tracking systems.
• Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and performing periodic oversight visits to sites and/or vendors to assess progress and compliance.
• Manage clinical trial budgets, providing ongoing financial reporting and projections to the finance group and facilitate the development of clinical trial agreements, insurance and other relevant documents in conjunction with legal.
• Ensure the Trial Master File (TMF) is maintained throughout the trial and perform inspection readiness checks throughout the lifecycle of the trial.
• Serve as functional area reviewer of global clinical / regulatory submissions.
• Present study status reports of operational execution activities to senior management.
• Provide study‑specific mentor and training for in‑house Clinical Research Associate(s) and/or Clinical Trial Assistant(s).
• Participate in operational process improvement initiatives (including training, SOP review and development of work instructions/tools/templates).

• Bachelor’s degree in Life Sciences or similar; +7 years of clinical research experience at a Biotech/Pharmaceutical or CRO company; a minimum of 3 years of direct clinical study management experience in a full‑service outsource model as a clinical trial manager or clinical project manager is required.
• Experience managing early‑phase drug development studies is preferred.
• Oncology therapeutic experience is preferred.
• Global Clinical Trial Experience and the ability to support more than one clinical trial is required.
• Good working knowledge of the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines.
• Excellent communication skills, ability to build strong relationships with peers and cross‑functional team members and CRO/Vendor partners, experience mentoring clinical study staff and presenting to senior management.
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Must be able to travel routinely by car and plane.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a…