Fluent in English and Advanced in Spanish (mandatory).
Minimum of 5 years experience in clinical Operations management within biotech or pharma setting.
Experience & knowledge of clinical project management
Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
Understanding of regulatory environment, GCP/ICH, Inspection readiness
Experience working in an orphan disease field is a plus
Strong communication and interpersonal skills, with the ability to collaborate effectively across diverse functional areas.
Lead, manage and/or support and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCP.
Oversees the quality of the clinical operations for the studies he/she is in charge of.
Ensure that study is Inspection ready through the study lifecycle and partake in CAPAs when needed.
Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables.
Collaborates with Clinical Science, data management and statisticians ensuring data base maintenance, interim and final database locks.
Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies), lab supplies, lab tracking of samples.
Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
Ensuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelines
Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
Collaborating closely with data management for the study activities.
Ensures accurate maintenance and archiving of study records.
Oversees TMF Management and/or support of study budget and timelines.
Management of vendors, including a CRO, to the required standards.
