Michael Weinstein Email & Phone Number

• Was in charge of gathering the following information pertaining to clinical trial process:- General Study Information- Randomization Information- System Objectives and Modality- Site, Subject and User Type Information- Study Timelines / Milestones- Study Duration- Study Regions and Investigator Meetings- Languages and Translation Information- Drug Management Information- System Modules and Configuration- Alerts- Web Cognos Reports• Carried responsibilities for writing user requirement specifications and clinical trial project support documentation.• Managed process of writing and reviewing functional specification evaluation process/project plans.• Planned and facilitated meetings with corresponding internal team and external clients.• Ensured communication of all project changes to project team members, including pharmaceutical vendors based on the predefined project schedule.• Arranged that the development, validation and ongoing support are performed according to all applicable SOP’s and working Instructions.• Managed project-specific sponsor teleconferences and facilitated training of clinical study staff at investigator meetings.• Monitored billed project time and budget levels.• Administrated Project Manager Study Maintenance (SM) activities during project start-up phase.• Designed and managed implementation of support for PM-SM during project maintenance phase.• Facilitated all software changes for corresponding systems based on ongoing modifications of clinical trial requirements.