12-month renewable salaried contract
**only considering candidates in the Pacific or Central time zones**
*Must have global phase 3 asthma experience*
*Must have experience working for small pharma*
Job Description:
- 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:
- 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
- Global Phase 3 experience required, APAC preferred
- Strong knowledge of asthma therapeutic area and acute care/hospital trial settings required
- 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