Clinical Trial Manager

Role Overview

• Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
• Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
• Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
• Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
• Proactive identification and management of study related risks
• Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
• Responsible for reviewing and managing study related plans, processes including; Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
• Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
• Reviews and approves essential document packages to enable timely site activations
• Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
• Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
• Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
• Perform periodic QC of the TMF
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• Ensures the study is inspection ready always
• Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
• All other duties as assigned

Requirements

• Bachelors degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
• 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Experience with budget forecasting and management
• Experience with clinical studies in oncology
• Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
• Proven proficiency in overseeing large complex studies being managed in house and by a CRO
• Demonstrated ability to lead teams and work in a fast-paced team environment
• Experienced and enjoys building relationships with KOLs and site personnel
• Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
• Demonstrated ability to build and deliver on patient enrollment strategies
• Excellent interpersonal and decision-making skills.
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• Demonstrated ability to comprehend complex scientific concepts and data
• Proficient in reviewing and assessing clinical data
• Possesses excellent planning, time management & coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Experience in working in a small organization
• Excellent written and oral communication skills.

Tech Stack

• Google Cloud Platform

Benefits

• Actual compensation packages might include bonus, stock, benefits and/or other applicable variable compensation.