Senior Clinical Trial Manager

Role Overview

• Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time, within budget, and in compliance with department procedures, applicable regulations and quality standards
• Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
• Develop plans for systems and materials required to support the efficient execution of clinical studies and is responsible for effective management during the conduct of the study
• Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management and other stakeholders
• Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
• Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
• Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
• Develop study budgets and is responsible for accurately forecasting and managing study expenses
• Oversee site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools
• Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensure compliance with study plans such as the study protocol, monitoring plans, and recruitment plans
• Conduct monitoring activities as needed
• Ensure the smooth and efficient closure of studies through development of plans for completion of data verification & review, planning & facilitation of database lock activities, determination of site & IRB/EC readiness for closure, statistical analysis and clinical study report development
• Participate in the identification, qualification, selection and management of vendors providing support to clinical studies
• Provide oversight and support for assigned clinical operations study team members
• Leads cross-functional team meetings, ensuring study goals and priorities are clear.
• Professionally interacts with investigators and site staff, vendors, key opinion leaders and consultants
• Ability to identify, mitigate and manage study risks
• Responsible for maintaining ongoing study audit readiness and participates in internal or regulatory authority audits
• Provide guidance and support to less experienced team members
• Fosters a collaborative and knowledge-sharing environment, promoting continuous learning within the team
• Ability to provide oversight to multiple studies
• Participate or may facilitate department or project initiatives under the direction of department management or lead clinical trial manager
• Uphold company mission and values through accountability, innovation, integrity, quality and teamwork
• Support and comply with the company’s Quality Management System policies and procedures
• Maintain regular and reliable attendance
• Ability to act with an inclusion mindset and model these behaviors for the organization
• Ability to work a designated schedule
• Ability to work on a mobile device, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day
• Ability to work on a computer and phone simultaneously
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.
• Ability to attend off-site meetings and conferences as needed

Requirements

• Bachelor’s degree in the life sciences or field as outlined in the essential duties
• 5+ years of experience in clinical research
• 1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
• Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
• Experience writing, reviewing and editing protocols
• Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
• Authorization to work in the US without sponsorship
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation
• Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers).

Tech Stack

• Google Cloud Platform

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage