- Descripción From Marlex Great People, we are searching a Clinical Project Manager to work in an important pharmaceutical laboratory, with their headquarters in Barcelona:
What responsibilities will you have?
• 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
Ventajas sociales o económicas The option to be a part of a growing company, in which you'll be able to develop your professional career.
Permanent contract
Partial remote work
Clinical Project Manager (Pharma) Marlex Great People | (2) ofertas activas Empresa que ofrece el puesto: Marlex Great People
Barcelona 19 Jun. - - Descripción From Marlex Great People, we are searching a Clinical Project Manager to work in an important pharmaceutical laboratory, with their headquarters in Barcelona:
What responsibilities will you have?
• 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
Número de vacantes: 1 Modalidad de trabajo: Híbrido (25%) Tipo de contrato: Permanent contract Remuneración anual: Negotiable Ventajas sociales o económicas The option to be a part of a growing company, in which you'll be able to develop your professional career.
Permanent contract
Partial remote work
" Requisitos • Degree in Life science
• 3+ 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
• Knowledge of basic statistics and good skills in Microsoft office
• High English level (oral and written)
• Ability to work independently and lead multidisciplinary cross-functional team
Estudios mínimos Diplomado Idiomas Inglés nivel Alto.
Experiencia mínima 2 años Disponibilidad para viajar Ninguna
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