Project Specialist - Poland - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. At Parexel FSP , you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients. We are looking for a Senior Clinical Trial Associate (Project Specialist) 100% home based in Poland, Spain, Serbia or Romania. Your tasks will be • Provides logistical support to one or more global study management teams (SMT). o Develops and maintains effective working relationships with SMT members, affiliate team members, and vendors. o Assists Clinical Trial Manager (CTM) with effective communication between the SMT and Affiliates. o Coordinates the management of all global supplies utilizing the designated systems in collaboration with the CTM throughout the course of the study o Coordinates and organizes study related meetings in collaboration with the Clinical Program Leader (CPL) and CTM including the development and production of presentation materials. o Consolidates study information for study trackers and databases. o Supports the protocol feasibility, country, and site selection process. o Supports CTM in technical and logistical study processes. • Tracks and maintains study information and documentation and reports on study progress. o Maintains accurate tracking and reporting of Study Management data. o Coordinates and maintains the contact details of core SMT and Clinical. Operations teams, including country contacts and distribution lists o Oversees the timely tracking of Health Authority (HA)/IRB/IEC submissions and approvals in CTMS. Identifies any delays and raises issues to the CTM and appropriate Country Study Manager (CSM). o Provide IRB/IEC and HA submission documentation and all other supplementary documentation to affiliates or Product Development Regulatory (PDR), as appropriate. • Maintains and ensures the completeness of the Study-Level Trial Master File (TMF) in accordance with SOP requirements under the direction of the CTM. • Identifies and contributes to areas of best practice and process improvements. Proactively incorporates learnings and recommendations from other study debriefs and best practices. • Organizes agendas and minutes for team meetings. • Manages touchpoint study area according to global standards, including set-up, access rights, and maintenance of study-related documents. • Manages client system platform access rights and follows up on site training progress. • Ensures appropriate tracking and dissemination of Safety Reports during studies. • Assists in the coordination of activities to ensure CRO and vendor delivery against the contracted scope of work. Coordinates communication for defined tasks and tracking information between the study team and vendor. • Complies with all required training curricula. • Completes timesheets accurately as required. • Submits expense reports as required. • Updates CV as required. • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements. From you we expect: • Bachelor’s degree, preferable life sciences or nursing equivalent • Minimum of 2 years’ experience working as project specialist in clinical research or health career-related industry or equivalent of education and experience. • Experience of working as part of larger global teams with a proven ability to make an active contribution to the team’s performance and team working. • Knowledge of ICH/GCP • Solid experience in TMF • Experience in WORD, EXCEL, PowerPoint, other software and system. • Fundamental understanding of filing systems and organizational tools • Proficiency in written and spoken English Skills: • Self-motivated and resourceful; move actions forward without the need for continual supervision • Communication, collaboration, and teamwork • Attention to detail • Personal Organization • Proficient computer skills across multiple applications • Proficient in written and spoken English language required We will offer you Premium salary. Attractive benefits. Medical care plan: Health, Dental & Vision. Life Assurance. Excellent work environment. Culture of teamwork and collaboration. People who motivate and face challenges together. Innovative technology. Excellent training. Join a global community where you can transform your career into a life-changing achievement. Base Pay Range for Poland: PLN 110,000 to 120,000. Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. Apply directly or contact us via email at [email protected]