Clinical Project Specialist

Job description

For the past 25 years, ProPharma 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. ProPharma 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, ProPharma 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. Job Summary 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. Essential Functions 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. 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, 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 communication and interpersonal skills, with the ability to work effectively with study team members and stakeholders at varying levels of responsibility. 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. Educational Requirements Bachelor’s degree is preferred. Candidates without a formal degree who have comparable depth and breadth of relevant training and experience and meet job-specific criteria 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. #LI-JB1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***