Primary point of contact for Clinical Operations aspects of designated projects: act as main contact for CROs and other clinical providers and for internal clients
Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects in collaboration with CRO
Responsible for risk mitigation strategies, associated action plan and issue resolution in collaboration with CRO
Responsible for oversight the project development to ensure deliverable on time and within budget
Manage the relationship with CRO and clinical providers, identify needs and evaluate alternative business solutions and strategies
Responsible for internal reporting on the status of the projects
Provide direction and support to the internal client staff collaborating at some point with the study
Collaborate with Business Development (BD) and Finance to ensure timely completion of CDAs, MSA, change orders
Track clinical operations project deliverables using appropriate tools
Manage the project budget: track budget deliverables using appropriate tools
Apart from the tight supervision of CROs and other clinical providers, the clinical operations team also works closely with internal clients in order to comply with internal processes, especially related to control of budget/orders/expenses/invoices and management of contracts with sites, CROs and providers.
Professional development and career planning
100% in-person
Flexible hours: 8-10 a.m. / 4-6 p.m., Monday through Friday
15% bonus
Health insurance
27 working days of free vacation
Requisitos mínimos
Bachelor's Degree in medicine, science or equivalent degree. At least 3 years' experience within clinical trials and study operations
Specific therapeutic experience in CNS and Oncology, will be desirable
Comprehensive knowledge of ICH-GCP is essential along with excellent communication, teamwork, planning, decision-making, negotiation, conflict management and time management skills
No travelling is expected
Proven fluent in written and spoken English is a must
Computer literate
Fluent in basic finance-control activities (i.e., elaboration of budgets; tracking of expenses and invoicing…)
