Clinical Project Specialist

For the past 25 years, Pro Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. Pro Pharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro Pharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Clinical Project Specialist position is responsible for providing administrative and project management support for assigned clinical studies and projects, working closely with study teams to support efficient, compliant, and timely study execution.

Performs administrative and project support activities related to clinical trial execution, including assisting with the development, formatting, review, and reconciliation of study‑specific documents and information. Supports the day‑to‑day operations of clinical studies in compliance with applicable SOPs, ICH/GCP guidelines, study requirements, and other applicable regulatory requirements. Assists with document collection, dissemination, tracking, filing, and reconciliation in accordance with organizational processes, applicable SOPs, and regulatory requirements.

Assists with the development and distribution of site binders and study materials, as requested. Tracks and maintains study‑specific information using databases, spreadsheets, trackers, and other study tools. This may include, but is not limited to, clinical and non‑clinical supplies, site activities and metrics, study status information, and quality‑control activities across various components of the clinical trial. Sets up and coordinates meetings, prepares agendas as applicable, takes meeting 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 other cross‑functional stakeholders to complete assigned study execution activities and deliverables. Supports study material development, maintenance of study trackers, and other project‑specific documentation as assigned. Supports study systems and operational activities, which may include CTMS, eTMF, EDC, IVRS/IWRS, training records, site payments, study access, and other study‑specific platforms or processes, as applicable.

May participate in process improvement, quality‑related initiatives, and departmental activities associated with study execution and operational deliverables. Other duties as assigned.

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, including Outlook, Word, Excel, and 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…