Premier Research

Compliance

• Supervises, mentors, and motivates reporting associates
• Develops and implements strategic plans and objectives
• Participates in the development of corporate methods, techniques and evaluation criteria
• Consults and advises on laws, regulations, and guidelines on clinical trials
• Develop and maintain an excellent working relationship with the FDA, EMA and other regulators
• Provides leadership in the preparation of regulatory strategies
• Provides strategic and tactical guidance to clients
• Partners with Business Development to cross-sell Premier’s clinical CRO services
• Presents at applicable industry engagements
• Performs additional duties and assignments as requested

Vice President, Regulatory Strategy

Operations

• Ensures infrastructure compliance so as to support a global network
• Analyzes, designs, acquires and implements projects for server, application, network or other infrastructure systems
• May contribute to the development, testing, evaluation or design of the infrastructure architecture used throughout the IT solution set
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions
• Takes the initiative to resolve a wide range of issues in creative ways
• Act as a subject matter expert for server, OS, VM and storage infrastructure
• Play a lead role in systems deployments, configuration, monitoring and reporting
• Maintain infrastructure operations and keep documentation current as changes are made
• Analyze and evaluate anomalous server and system activity in the context of Premier SOPs and take appropriate action
• Lead in troubleshooting and problem solving a wide variety of client issues related to server and application performance
• Ensure that the IT infrastructure is compliant with all regulatory requirements (i.e. 21 CFR Part 11), existing SOPs and guidance documents , and generally accepted industry practices
• Coordinate high level resources, project schedules, and communications for infrastructure changes, upgrades and troubleshooting as required
• Research and recommend improvements to the technical infrastructure relative to Data Center, Server, and application architecture
• Schedules and chairs meetings with key staff to facilitate operational requests within IT and the business.

Senior Infrastructure and Operations Engineer, Azure

Project Manager

• Ensures successful management and coordination of efforts assigned to all members of the global project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
• Ensures adherence to project budget and scope of work to realize project profitability
• Ensures all project tasks are completed in accordance with project plans and in compliance with standard Premier Research processes, policies and procedures
• Acts as the primary liaison between Premier Research and the customer for all assigned projects and chairs project team meetings and teleconferences
• Assists in Business Development activities, including proposal development and leading proposal presentations in partnership with Business Development and Scientific Account Leadership
• Develops strong relationships with current clients to generate new and/or add-on business for the future

Senior Project Manager, Dermatology

• Independently prepare IND Modules for routine submissions
• Support regulatory affairs leadership in preparation of complex submissions
• Perform thorough independent background research through all pertinent search engines
• Ensure that documents appropriately evaluate and present data and methodology
• Navigate and obtain information for projects from all available resources
• Produce timely, scientifically accurate data summaries
• Construct documents in a manner consistent with applicable regulations and guidance
• Serve as Regulatory representative in department discussions
• Interface with international affiliates on regional regulatory strategy

Regulatory Strategy Associate

Customer Support

• Populates the Metadata Repository based on approved impact assessments and/or Case Report Form (CRF) specifications and annotations
• Creates CRF specifications and annotations based on impact assessments and documented decisions
• Populates the metadata in the global library of the clinical data management system (CDMS)
• Creates new graphic CRF modules based on approved impact assessments
• Posts Data File Specifications, Statistical Guidance Documents, and other related documents to the Metadata Repository
• Manages the standards work flow change control process via the change control system
• Trains and follows internal and sponsor's standard operating procedures as applicable
• Liaison with the sponsor as needed to resolve issues that cannot be resolved within the organization
• Performs additional duties as assigned

Vice President, Regulatory Strategy

Senior Infrastructure and Operations Engineer, Azure

Senior Project Manager, Dermatology

Regulatory Strategy Associate

Standards Support Specialist