• Must have experience working in a biopharmaceutical environment
• Must have experience managing diabetes trials

• Responsible for the conduct and management of one or several sponsored studies (Phase I to III)
• Facilitates strategic decisions and provides leadership direction within the clinical operations function to optimize management of scope, financials and schedule as it impacts project execution
• Optimizes and leverages processes, tools, metrics, resources and systems to enable effective, efficient and compliant team performance and deliverables
• Leads and manages cross-functional project meetings
• Authors and/or reviews study documents such as study protocols, informed consent templates, monitoring plans, DSMB/Steering committee charters, Clinical Study Reports
• Manages processes related to DSMBs, CECs, Steering Committees
• Leads the selection process of target countries as well as the selection and qualification of principal investigators for clinical studies
• Oversees the organization and conduct of Kick-off meetings, Investigators‘ meetings and Coordinator meetings
• Responsible for quality management of a clinical program (i.e. authoring, implementation, and on-going assessment of quality management plans through ongoing data reviews and review of performance metrics)
• Responsible for clinical program drug supply forecasting
• Responsible for adequate resource planning across multiple projects
• In cooperation with other functional groups coaches, develops and trains junior staff on increasing responsibilities and core competencies
• Participates in the development process of internal SOPs, if required

Qualifications Required:

• Must have recent experience working for a small biopharmaceutical company
• Experience managing respiratory (asthma) clinical trials
• Scientific background with a minimum of a BS degree; advanced degree preferred
• A minimum of seven years of clinical research experience; 4-5 years as a project manager
• In-depth knowledge in clinical study design and experience in all aspects of conducting global clinical studies and phases of research
• Solid knowledge of ICH/GCP guidelines and regulatory requirements across regions for all clinical development phases
• Strong knowledge of therapeutic area and acute care/hospital trial settings preferred
• Demonstrates strong leadership and management skills with willingness to be heavily involved in the conduct of clinical studies
• Strong ability to work and problem solve independently with little guidance/supervision and a proactive approach
• Demonstrates internal and external customer expectation management and alignment
• Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives
• Ability to prioritize workload to meet multiple project timelines
• Excellent planning, organization and decision-making skills
• Ability to travel 
  

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