Clinical Trial Manager

This is a fully remote position, open to applicants in Argentina, +3 more countries.

📋 Description

• Oversee the execution of clinical study site management tasks by coordinating Clinical staff within a designated geographic area

• Ensure that site qualification, initiation, interim monitoring, site management, and study close-out activities adhere to protocols, study plans, and Worldwide SOPs

• Guarantee the quality and promptness of clinical deliverables for assigned programs and/or regions

• Collaborate with Project Management to establish site management objectives and monitoring strategies

• Provide leadership and guidance to the clinical site management team from the start of the study until closure

• Act as the main Site Management contact for monitoring and site-related activities

• Manage monitoring deliverables in accordance with the study budget and identify activities that fall outside the scope

• Tailor study-specific Site Management quality documents, including Clinical Monitoring Plans

• Supervise CMP compliance, site visits, trip reports, and follow-up letters

• Review protocol deviations and action items from visits

• Train CRAs on the clinical aspects of studies

• Develop and implement strategies for patient recruitment and monitor enrollment

• Enhance site data quality and ensure data integrity

• Track and evaluate Site Management deliverables, trends, analytics, financial performance, metrics, and resource allocation

• Ensure TMF compliance and readiness for inspections

• Design a regional monitoring strategy and anticipate site visit and staffing requirements

• Review and finalize trip reports

• Conduct site qualification, initiation, interim monitoring, and close-out visits as necessary

• Address and escalate monitoring and site-related issues

• Identify and mitigate potential risks

• Represent Site Management as the primary project contact when necessary

• Conduct co-visits to ensure quality at the site, CRA, and study procedures

• Perform additional duties as assigned

⛳️ Requirements

• Exceptional interpersonal, oral, and written communication skills in English

• Outstanding planning, organizational, presentation, and time management abilities

• Adaptability to change

• Capability to manage multiple and diverse tasks

• Proficiency in negotiating and influencing diplomatically

• Initiative and effective problem-solving skills

• Ability to prioritize tasks, plan ahead, and achieve goals with minimal supervision

• Competence in leading and motivating a remote team

• Ability to contribute to initiatives related to monitoring and site management processes

• Strong customer-centric approach and professional interaction with sponsors

• Comprehensive understanding of clinical research principles and processes

• In-depth knowledge of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements

• Experience in the relevant therapeutic study area

• Thorough familiarity with standard operating procedures

• Proficient in Microsoft Office, eCRF, and IVRS software

• Skilled in IxRS, CTMS, and EDC systems

• Bachelor's degree or equivalent with a focus on biological, physical, or health studies and a minimum of three years as a Senior Clinical Research Associate (or equivalent)

• OR an associate degree or equivalent education/training with at least five years as a Senior Clinical Research Associate; nursing degree or equivalent life science degree preferred

• OR at least six months of experience as CTM/LCRA (or equivalent), supporting the main CTM and coordinating clinical operations

• Valid current passport is required

• Driving license is required

🏝️ Benefits

• Diverse and inclusive workplace

• Supportive, team-oriented environment

• Accessible, hands-on leadership

• Equal employment opportunities

• Travel is required