Project Support Associate

The PSA is responsible for coordinating project activities, maintaining project documentation and systems, supporting financial and operational tracking, and contributing to continuous process improvement initiatives. The ideal candidate is highly organized, customer-focused, detail-oriented, and thrives in a fast-paced clinical services environment.

Key Responsibilities

• Support the management and execution of assigned clinical labeling projects and studies from initiation through completion.
• Utilize internal systems and proprietary applications to process project specifications, label requirements, randomization parameters, and study documentation.
• Collaborate effectively with cross-functional teams including Quality Assurance, Production, and Client Services to ensure project success.
• Maintain accurate and timely project documentation.
• Monitor project timelines and proactively communicate risks, delays, or required escalations to appropriate stakeholders.
• Ensure all activities are performed in compliance with cGMP requirements, company quality standards, Work Instructions and Standard Operating Procedures (SOPs).
• Support the resolution and closure of quality events, deviations, and problem reports in partnership with QA.
• Manage and prioritize multiple project-related tasks while maintaining a high level of accuracy and customer service.
• Participate in continuous improvement initiatives to enhance operational efficiency, productivity, and customer satisfaction.
• Demonstrate ownership, accountability, and professionalism in all aspects of project support activities.
• Promote company values, vision, and a culture of quality and compliance.

Required Qualifications

• Bachelor’s degree is preferred, ideally in life sciences, healthcare, or related field.
• Minimum of 2–3 years of experience in clinical trial project coordination, project management support, or a related pharmaceutical services environment.
• Strong proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.
• Excellent organizational, analytical, verbal, and written communication skills.
• Ability to manage multiple priorities and meet strict deadlines in a dynamic environment.
• Strong customer service mindset with effective interpersonal and collaboration skills.
• Experience working within regulated environments and adherence to quality standards and SOPs.

Preferred Qualifications

• Previous experience in clinical packaging, labeling, or clinical supply chain operations.
• Familiarity with project planning or project management tools such as Microsoft Project.
• Knowledge of clinical trial systems and applications related to labeling, specifications management, and randomization.
• Understanding of GMP/GxP regulations and clinical trial processes.

Core Competencies

• Attention to Detail
• Project Coordination
• Cross-Functional Collaboration
• Time Management
• Problem Solving
• Customer Focus
• Regulatory Compliance
• Continuous Improvement