Primary Responsibilities
Identifies project guidelines and communication needs by:
- Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents
- Defining project plans (i.e. timelines, milestones and limitations for project staff)
- Establishing project reporting schedules
- Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule
- Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)
Performs project analysis and management by:
- Identifying critical project success factors for tracking, analysis and reporting
- Determining needed resources for project completion and communicating needs to appropriate departmental managers
- Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project
- Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management
- Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting
- Understanding SOPs and working closely with QA for clarification and documentation of deviations
- Training and maintaining project team knowledge and applications of SOPs
- Communicating all protocol clarifications/revisions to project team
- Coordinating site management of data collection with internal and external teams
Provides project team leadership by:
- Leading by example with professional and collaborative conduct
- Developing and delivering team project training
- Establishing team performance expectations and guidelines
- Providing input to departmental managers of respective team members’ performance level
- Analyzing team performance for consistency/quality within established project guidelines
- Collaborating with the departmental managers for team coaching/mentoring
Supports Business Development efforts by:
- Collaborating with BD Director in the development and presentation of company capabilities calls/meetings
- Attending professional meeting(s) as Company representative
- Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services