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La logistique fluide, maîtrisée et sécurisée.
Clinical Project Manager – CRO
Location
Brazil
Posted
62 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Project Manager – CRO
SYNVIA
• 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.
Job 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).
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