Develop full service project plans for clinical trials or a program of studies and subsequently lead cross functional study teams in accordance with contractual timelines, client specifications and good clinical practices.
You will effectively manage the activities of assigned staff, which may include directors, project managers and others in a manner that ensures all timeframes and targets are met and that costs are kept under control.
The senior scientific affairs specialist will utilize reference tools to obtain technical information for new assays as well as obtaining package inserts, and pricing from internal resources for new in-house assay validation efforts.
In this role, the selected candidate will be delivering successful working relationships with clients, cross functional project planning, scheduling and implementation, defining project scope, resource requirements and deliverables, risk migration strategies, associated action plan and issue resolution.
Monitoring and managing project-specific email accounts, incoming faxes and telephone calls. Preliminary triaging of incoming information to determine classification, priorities and time frames for subsequent activities.
Participate in business development activities and client meetings by assisting in the preparation and presentation of Clinical Operations information in Bid Defense meetings, Kick-Off meetings and business proposals.
The Laboratory Manager will be responsible for monitoring and reviewing proficiency testing, operational and department budget, laboratory quality control data, and quality control systems and corrective actions.
Responsible for global pharmaceutical supply for all phases and pharmaceutical development activities on-going at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of the client.