Gerente de Operações Clinicas - Brazil
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Accountable for execution and oversight of local operational clinical trial activities in a country in assigned protocols in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, DPS/OFAC, maintenance of financial systems. Financial forecasting in conjunction with CRD.
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.
Responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to development of local/Int'l SOPs. Oversees CTCs and may oversee COMs (also across countries), both as applicable.
Coordinates and liaises with CRM, CTC, CRA, Finance and Legal to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Ops to align country timelines for assigned protocols. Works closely with CRD. Provides support and oversight to local vendors as applicable.
Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local filing, archiving and retention requirements, insurance process management. Enters and updates country information in clinical trial and finance systems.
Master's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related course;
Previous experience in clinical research required;
Strong leadership skills / Requires expertise of core clinical systems, tools and metrics;
Advanced English skills required;
Strong coordination and organizational skills required.
: Clinical Research Monitor Job Title:Assoc. Dir, Clinical Research
Local principal: LATAM-Brasil-SP-São Paulo
Status do funcionário: Regular
Número de vagas: 1
Company Trade Name:MSD