Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate the clinical operational delivery strategy that aligns with the protocol, Sponsor objectives, contracted scope, timelines, and budget.

• Oversee Clinical Operations activities from study planning through to completion across various countries and regions.

• Maintain training curricula for protocols and amendments for assigned CRAs, ensuring retraining occurs after any amendments.

• Convert protocol requirements into actionable clinical delivery plans and create study documentation, including CRFs, monitoring plans, reference manuals, and tracking logs.

• Act as the main clinical contact and resource for CRAs, sites, and clients.

• Collaborate with the Project Manager and functional leads to develop monitoring strategies and schedules.

• Ensure that site source documents, CRFs, and/or EDC are accurate, complete, and compliant with GCP, ICH guidelines, and protocol requirements.

• Recognize scope changes, evaluate their impacts, and communicate these to the Project Manager.

• Identify clinical risks, as well as underperforming or high-risk sites, and implement corrective or recovery plans.

• Engage in Sponsor meetings to present the Clinical Operations status, risks, trends, and recommendations.

• Contribute to the identification, selection, and global recruitment strategies of sites.

• Ensure that sites are operationally prepared before initiation and enrollment, and monitor site performance using metrics and indicators.

• Communicate study progress to relevant stakeholders and develop corrective action plans as necessary.

• Attend Investigator Meetings and other Sponsor or agent meetings as required.

• Lead and/or manage CRAs, Site Managers, and regional/country Clinical Operations resources.

• Design operational enrollment strategies, set recruitment expectations, and assess the need for additional sites or countries.

• Develop, implement, and sustain the Clinical Monitoring Plan.

• Determine suitable on-site, remote, centralized, and targeted monitoring activities.

• Review monitoring compliance, quality, findings, and trends, adjusting strategies according to emerging risks.

• Escalate and address significant findings.

• Participate in study-level risk assessments and translate risks into clinical monitoring strategies.

• Comprehend critical data, processes, and Critical-to-Quality factors.

• Partake in Bid Defense Meetings and present strategies related to Clinical Operations, site management, recruitment, monitoring, and RBM.

• Fulfill monitoring responsibilities as needed.

• Execute other clinical research duties as required.

⛳️ Requirements

• Bachelor's or master's degree in life sciences, nursing, or a related field.

• 2+ years of experience in clinical trial management.

• At least one year of experience as a clinical monitor.

• Therapeutic knowledge of CNS trial methodologies and scale management.

• Strong understanding of the overall drug development process, including study initiation procedures, clinical monitoring functions, drug safety and regulatory requirements, and report generation.

• Proficient in ICH/GCP guidelines, including E6(R2) and E6(R3), as well as Risk-Based Monitoring and RBQM principles.

• Excellent verbal and written communication skills, organizational abilities, time-management, customer service, and interpersonal skills.

• Strong leadership in global Clinical Operations and ownership from end-to-end.

• Capability to collaborate with the Project Manager while ensuring clear accountability in Clinical Operations.

• Ability to lead geographically diverse teams and influence without direct line-management authority.

• Capacity to work independently.

• Certified Clinical Research Associate (CCRA), as applicable under regulations.

• Experience in clinical risk management and cross-functional study-delivery leadership.

• Experience in proposal development and presenting during bid defense meetings.

• Familiarity with CTMS and eTMF systems.

• Willingness to travel internationally as required.

🏝️ Benefits

• Global/regional travel on an as-needed basis.

• Support for professional development.

• Continuous mentorship and performance evaluations (for CRAs under line management).