Clinical Project Manager – CRO

Role Overview

• Conduct trainings relevant to your role and keep records up to date;
• Manage clinical projects requiring interaction with various groups: multidisciplinary teams, data management, start-up, transportation/logistics, regulatory affairs, and quality assurance throughout the project lifecycle;
• Provide comprehensive, strategic support for all project management activities;
• Define and manage project scope, timelines, and deliverables from project initiation through close-out, ensuring the project plan is aligned with contractual requirements and addressing any necessary reconciliations;
• Schedule, plan, and document meetings with sponsors and the project team. Assess project issues and propose resolutions to the team, Head of Clinical Operations, and the sponsor;
• Assess project issues and propose resolutions to the team, Head of Operations, and the sponsor;
• Support the procurement department in sourcing, identifying, and qualifying vendors/suppliers;
• Identify and select research sites for project execution;
• Support the commercial and operations departments during the feasibility phase of clinical trials;
• Review commercial proposals related to clinical trials;
• Review and manage contracts with research sites and vendors;
• Attend initiation visits and, when necessary, site qualification visits, routine monitoring, and close-out visits at research sites;
• Participate in the preparation and review of project-related documents, including: budget, protocol, Informed Consent Form (ICF), Case Report Form (CRF), site qualification reports, monitoring reports, among others;
• Develop and implement corrective actions necessary to maintain project quality;
• Responsible for clinical trial training of the Synova team involved in the project;
• Develop study documents, including but not limited to: Project Management Plan, Pharmacovigilance Plan, Risk Management Plan, Monitoring Plan, Partner Management Plan, Pharmacy Manual, Laboratory Manual;
• Supervise team members remotely and on-site;
• Participate in the preparation and review of project-related documents, including: budget, protocol, informed consent form, forms, CRF, site qualification reports, monitoring reports, among others;
• Support the development of clinical research analysts;
• Ensure control of the study budget.

Requirements

• Bachelor's degree in Pharmacy, Biomedicine, or Nursing;
• Good Clinical Practice (GCP); experience with initiation visits, routine monitoring, close-out, site qualification, and project management;
• Experience working as a clinical research monitor (CRA) or as a clinical project manager;
• Advanced English.

Benefits

• Transportation allowance (Vale Transporte);
• Parking (subject to availability);
• Health insurance with no monthly premium for the employee, with co-pay for exams and consultations;
• Dental plan with employee co-pay;
• Life insurance at no cost to the employee;
• Flexible meal/food allowance;
• Pharmacy benefits/discount program;
• Synvia Partnership Club (education institutions, language schools, leisure and cultural activities);
• Partnership with SESC;
• Physical health program (TotalPass);
• Day Off – Healthcare Professional;
• Childcare assistance (according to internal policy).