Clinical Trial Manager, FSP

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

📋 Description

• Oversee the clinical operational and quality dimensions of assigned low- to moderate-complexity studies, ensuring compliance with ICH GCP standards.

• Take on the role of Clinical Study Manager for smaller or less complex projects as necessary.

• Create clinical tools, monitoring strategies, and guidelines, and contribute to the Data Quality Plan and Master Action Plan.

• Guarantee timely setup, organization, content, and quality of the relevant sections of the Trial Master File.

• Engage in the design of Case Report Forms (CRFs), CRF guidelines, informed consent templates, and other protocol-specific documentation.

• Work alongside project managers to prepare and deliver presentations at client meetings, bid defenses, and hand-off sessions.

• Collaborate with clinical and cross-functional teams, lead team meetings, and manage timelines, resources, interactions, and quality assurance.

• Implement and provide training on standardized clinical monitoring methodologies.

• Ensure timely archiving of study documents and materials.

• Prepare and track clinical activity timelines and metrics, offer status updates, evaluate projects, implement corrective actions, review monitoring visit reports, and manage the collection of CRFs and query resolutions.

• Monitor or co-monitor clinical trials to evaluate performance and fulfill contractual obligations.

• Conduct Accompanied Field Visits and oversee project financials in smaller regions as needed.

• Liaise with study sites concerning protocols, patient participation, case report forms, and other study-related matters.

• Coordinate study initiation activities and ensure timely submissions to ethics committees and regulatory bodies.

• Maintain the quality of essential documents to meet Regulatory Compliance Review standards and follow up on inquiries from ethics committees.

• Contribute to clinical activity forecasting.

• Manage clinical resources, allocate and delegate responsibilities, and identify additional resource needs.

⛳️ Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification.

• Over 5 years of prior experience providing the knowledge, skills, and abilities necessary for the role.

• A combination of relevant education, training, and/or directly related experience may also be considered.

• Proficiency in the English language.

• Familiarity with clinical monitoring standards, processes, and requirements.

• Understanding of pertinent regulations, including ICH/GCP and FDA guidelines.

• Competent computer skills, including proficiency in Outlook, Excel, Word, and automated systems.

• Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, and decision-making skills.

• Ability to work efficiently in a dynamic environment with complex or ambiguous situations.

• Capacity to assess workload against project budgets and adjust resources as needed.

• Knowledge of budgeting, forecasting, and financial management.

• Excellent attention to detail.

• Willingness and ability to frequently travel to site locations, both domestically and internationally.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work hours.

• Opportunities for collaboration and professional growth.

• Supportive mentoring and training environment.

• Global team collaboration.

• Exposure to scientific innovation and excellence.