MBA-2504-147
CLINICAL DEVELOPMENT LEAD
BARCELONA

Clinical Development Lead to join a growing pharma company, based in Barcelona

• Lead and manage a multidisciplinary clinical trial team, ensuring effective planning, evaluation and implementation of assigned clinical studies and programs
• Collaborate with colleague/investigator team to establish realistic project timelines and escalate any unresolved issues to higher management
• Organize and facilitate investigators meetings and internal meetings related to study execution and operational excellence
• Interact with investigation sites and CRAs/CROs/vendors to ensure appropriate study setup and conduct
• Monitor site performance, review site visit reports and monitor activities of quality control
• Assist in developing and review of study documentation; study protocol, IB, treatment plans, informed consent forms and other essential study documents
• Support compilation of study regulatory documents for submission and communication with internal/external stakeholders
• Review of medical/scientific data quality, coordinate data analysis and interpretation of results
• Interact with medical writer to ensure completion of Clinical Study Report (CSR)
• Setup and maintain Trial Master File (TMF), Clinical Trial Management System (CTMS) in collaboration with colleagues/vendors

Essential requirements

• Life science degree with 5 years of clinical operations experience with strong management experience in planning, driving, reporting, and publishing clinical studies (interventional, observational, early to late phases)
• Previous experience in a pharmaceutical company/CRO is highly desirable
• Thorough knowledge of Good Clinical Practices (GCPs), clinical study design, regulatory processes, and global clinical development process
• High English level (oral and written)

Detalles / Details