Clinical Project Specialist

About the role

ProPharma partners with biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies through an advise-build-operate model across the complete product lifecycle. The Clinical Project Specialist provides administrative and project management support for assigned clinical studies and projects, collaborating closely with study teams to ensure efficient, compliant, and timely study execution.

Responsibilities

• Provides administrative and project support for clinical trial execution, including development, formatting, review, and reconciliation of study-specific documents and information.
• Supports day-to-day operations of clinical studies in compliance with applicable SOPs, ICH/GCP guidelines, study requirements, and other regulatory requirements.
• Assists with document collection, dissemination, tracking, filing, and reconciliation per organizational processes, SOPs, and regulatory requirements.
• Develops and distributes site binders and study materials as requested.
• Tracks and maintains study-specific information using databases, spreadsheets, trackers, and other study tools, including clinical and non-clinical supplies, site activities and metrics, study status, and quality-control activities.
• Sets up and coordinates meetings, prepares agendas, takes minutes, tracks action items, and distributes meeting materials.
• Proactively identifies, communicates, and escalates issues or risks that may impact assigned study or functional deliverables.
• Works closely with study team members, project managers, and cross-functional stakeholders to complete assigned study execution activities and deliverables.
• Supports study material development, maintenance of study trackers, and other project-specific documentation.
• Supports study systems and operational activities, including CTMS, eTMF, EDC, IVRS/IWRS, training records, site payments, study access, and other study-specific platforms or processes.
• May participate in process improvement, quality-related initiatives, and departmental activities associated with study execution and operational deliverables.
• Performs other duties as assigned.

Necessary Skills and Abilities

• Excellent verbal and written communication, interpersonal, and organizational skills.
• Strong attention to detail with the ability to manage multiple priorities, deadlines, and study-related activities simultaneously.
• Excellent computer skills with experience using Microsoft Office applications (Outlook, Word, Excel, PowerPoint) to prepare trackers, reports, presentations, tables, and other study documentation.
• Experience with email, calendar, and virtual meeting platforms.
• Experience with clinical trial systems such as CTMS, eTMF, EDC, IVRS/IWRS, or similar systems is preferred.
• Ability to work proactively, prioritize tasks, identify potential issues, and complete assigned activities with appropriate independence and minimal supervision.
• Strong communication and interpersonal skills with the ability to work effectively with study team members and stakeholders at varying levels.
• Ability to clearly document, summarize, and communicate study-related information.
• Ability to build and maintain positive and collaborative working relationships with management, peers, project teams, sites, and other stakeholders.
• Demonstrated ability to adapt to changing priorities and support multiple studies or projects as needed.

Qualifications

• Bachelor’s degree is preferred; candidates without a formal degree who have comparable depth and breadth of relevant training and experience may be considered.

Experience Requirements

• 2+ years of experience in the pharmaceutical, biotechnology, CRO, or clinical research environment is preferred.
• At least 1 year of experience in a Clinical Project Specialist, Clinical Trial Assistant, Clinical Trial Coordinator, Project Coordinator, or comparable clinical operations support role is strongly preferred.
• Experience supporting multiple clinical studies, project teams, or study-related systems and trackers is preferred.