Clinical Trial Manager / Senior Clinical Trial Manager

Role Overview

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work
• Primary clinical point of contact with the client
• Collaborate with PM on monthly invoicing and variance management of clinical budget
• Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
• Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices
• Generate potential site list from key stakeholders and drive site feasibility process
• Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
• Develop and finalize the country recruitment/retention strategy
• Develop timely and effective communication and good working relationships with investigators and study team
• Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
• Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
• Support in planning and conducting investigator meetings
• Review and/or approve of IP release packages
• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees
• Develop clinical monitoring strategies for assuring study timelines are met
• Generate and utilizes metric reporting to ensure that the study is conducted per plan
• Responsible for eTMF implementation and management
• Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA)
• Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
• Work closely with PM for project-specific resourcing issues
• Escalate pertinent CRA performance and site compliance issues when necessary
• Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
• Manage processes for investigational product (IP) including drug accountability and reconciliation
• Support business development and marketing activities as appropriate

Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Ability to travel domestically and internationally including overnight stays.

Tech Stack

• Google Cloud Platform

Benefits

• discretionary annual bonus
• health insurance
• retirement savings benefits
• life insurance
• disability benefits
• parental leave
• paid time off for sick leave and vacation