Clinical Study Manager

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

📋 Description

• Develop and sustain essential clinical study materials and tools, facilitating reviews with both team members and clients.

• Create and oversee study tracking tools, metrics, systems, and reporting processes.

• Provide support for protocol training, client and site management, and oversee the escalation and resolution of site-related issues.

• Establish, monitor project metrics, and track deliverables associated with projects.

• Communicate project status updates to clients and internal teams.

• Coordinate team and sponsor meetings, resolving cross-functional action items effectively.

• Manage site activities from initiation through closure, which includes site selection, submissions, document collection, negotiations, initiation, enrollment, monitoring, communications, and closing activities.

• Ensure data quality at sites, along with compliance with protocols and regulations, adverse events management, and protocol deviations tracking.

• Maintain investigator site files and ensure that all sites have the necessary study materials.

• Develop strategies for recruitment and site engagement.

• Ensure that project plans and Trial Master File documents are up-to-date, consistent, audit-ready, and compliant with regulations.

• Assist in the development, testing, and implementation of EDC, CTMS, TMF, and device accountability systems.

• Collaborate with data management and biostatistics teams to generate reports, review data, and identify trends.

• Support clinical deliverables for regulatory submissions and contribute to the creation of clinical study reports.

• Ensure compliance with contractual agreements, departmental guidelines, SOPs, regulations, and ICH Guidelines.

• Lead multidisciplinary clinical projects for studies that are simple to moderately complex.

• Manage cross-functional teams effectively.

• Possess an understanding of investigational products and the Medical Device Development Process.

• Review monitoring reports for accuracy and compliance.

• Conduct and summarize literature searches as needed.

• Assist with clinical audits for sites and sponsors, as well as FDA/competent authority inspections.

• Organize and manage Investigator Meetings efficiently.

• Select and oversee Core Laboratories.

• Select and manage safety committees such as DSMBs or CECs.

⛳️ Requirements

• Bachelor’s degree or equivalent experience in a relevant field.

• A minimum of 3 years of pertinent clinical trial and/or monitoring experience.

• Experience in project management.

• Proficiency in English and the local language, if applicable, is required.

• Strong knowledge of Good Clinical Practices.

• Understanding of regulations relevant to medical device trials at various development stages.

• Familiarity with the clinical trial process.

• Understanding of the site escalation process in relation to compliance issues.

• Multidisciplinary knowledge covering at least two therapeutic areas.

• Familiarity with the medical device development process from pre-clinical stages to commercialization.

• Awareness of the role of data management and biostatistics in clinical trials.

• Insight into the type and quality of data required from clinical trials and its presentation.

• Capability to communicate effectively with physicians, healthcare professionals, study coordinators, and IRB/EC/REB personnel.

• Proficient in preparing presentations and articulating complex information clearly and professionally; strong verbal communication skills.

• SoCRA or ACRP certification is preferred, though not required.

• Ability to meet specified physical demands, including occasional lifting/moving of up to 25 pounds and extensive use of computer keyboards.

• Willingness to travel as necessary, typically 20–30% of the time.

🏝️ Benefits

• Equal employment opportunity.

• Reasonable accommodations for individuals with disabilities.

• Pre-employment background and drug screening processes in compliance with local, state, and federal laws.