Project Specialist - FSP

Work Schedule

Environmental Conditions

Job Description

In this exceptionally dynamic Project Specialist role, you will provide high-level end-to-end support services and oversight to increase efficiency and compliance across various Functional Departments. You will play a pivotal role in managing complex studies and programs, ensuring that project deliverables and targets are met to world-class standards.

• Coordinate and lead all aspects of metrics in various systems to ensure flawless operations.
• Coordinate and support assigned PSS staff as Lead, working closely with functional leads to determine efficient operational performance.
• Introduce innovative ideas and smart new ways of working to help study teams maintain audit readiness.
• Support the creation, implementation, and change management for departmental and cross-functional process improvements and enhancements.
• Conduct risk assessment and analysis to avoid possible deviations and ensure strict compliance with established processes.
• Provide comprehensive oversight and follow-up on study-level activities to minimize inconsistencies and ensure compliance with systems, organizational, and customer processes.
• Coordinate, lead all aspects of, and follow up on systems and training for various Functional Departments, with the goal of achieving training compliance above 99%.
• Join external meetings and teleconferences with clients as needed, and contribute to the development of presentations regarding performance indicators, measurements, updates, and possible obstacles.
• Coordinate metrics in CRG's VV eTMF and Client eTMFs, including reconciliation of File Reviews.
• Update and maintain trackers and data repositories, analyze results, and build action plans for the Project Lead/CTM.
• Provide Clarity support by reviewing actual hours coded each month, identifying miscoding, and evaluating spend compared to budget.
• Identify risks and communicate them in advance to Functional Leads and Client representatives.
• Perform additional duties as necessary to support study teams and meet departmental and company objectives.

• Bachelor's degree or equivalent experience in a relevant field of study.
• Previous experience (2+ years) that provides the knowledge, skills, and abilities to perform the job effectively.

• Comprehensive understanding of PSC tasks, applicable manuals, eTMF, and File Review processes.
• Awareness of audit/inspection processes and relevant rules and advisory materials.
• Expert knowledge of applications (e.g., Excel), systems, or processes.
• Strong organizational skills and attention to detail, with proven ability to balance multiple tasks efficiently.
• Ability to analyze project-specific data/systems to ensure accuracy and efficiency.
• Strong customer focus and ability to adjust workload priorities to meet changing project timelines.
• Knowledge of ICH GCP, SOPs, and clinical trial life cycle.
• Advanced English proficiency (verbal and written).
• Proficient computer skills, including MS Office (Word, Excel, PowerPoint), and ability to master clinical trial database systems.
• Strong collaboration and communication skills, with the ability to shift prioritization according to project needs.
• Ability to work effectively in a team or independently.
• Good negotiation skills.