FSP Senior Clinical Trial Specialist

For the past 20 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. As the world's largest RCO (Research Consulting Organization), 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 Senior Clinical Trial Specialist (Sr CTS) supports moderately complex clinical trial activities in support of the Clinical Trial Manager(CTM). The Sr CTS works closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The Sr CTS may assist with Service Provider oversight and management. They will identify issues in a timely manner and escalate to management as appropriate. They will support the CTM in ensuring the financial health of assigned clinical studies as well as oversight of study milestones. The core duties and responsibilities of the Sr CTS are delineated below. Essential Functions: Supports activities related to all phase of clinical studies including; study/site feasibility, start-up, maintenance, and close-out. Manages study and site essential documents review, collection, tracking, etc Supports the initiation, preparation and maintenance of core study documents (Informed Consent Forms, study plans, site and patient materials, training and guidance documents, pharmacy, clinical supply and laboratory related documents, etc.) Study Trial Master File (TMF) oversight. Ensures required study documents received, reviewed and filed in the TMF in accordance with GCP and applicable regulations. Organization and preparation of study related meetings (agenda/ minutes /slides, etc.) Preparation, oversight and maintenance of study logs (risk/ issue/ decision logs, etc.) Supports and participates in departmental, study team, and service provider related meetings Lead and present at study related meetings Participates in study related collaborative efforts and reviews (protocol development, service provider selection, departmental initiatives, etc.) Complete monitoring visit report review and perform co-monitoring or monitoring oversight visits. Supports, tracks and triages site and service provider queries Supports rapid action to address both internal and site QA findings from audits Manages, coordinate and oversee the activities from third party service providers including timelines, contract deliverables, metrics, accruals, process planning, implementation, etc. General study tracking and maintenance, including but not limited to study status, enrolment, deviations, study levels documents and plans, etc. Supports oversight of clinical site performance, metrics, monitoring visits, etc. Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc. Able to work cross-functionally Review and verification of service provider activities Supports study reporting and tracking with applicable systems and technology Supports study lead in cross-functional alignment of study timelines Supports study lead in financial management of Service Providers (contract and invoice reconciliation) Necessary Knowledge, Skills, and Abilities: 5 or more years industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site management experience Previous site monitoring experience is preferred Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures Understanding of study phases and general knowledge of how they apply to clinical development Demonstrated ability to work independently and in a team environment Advanced knowledge of Word, Excel, and PowerPoint. Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet's, SharePoint, etc.) Knowledge of the principles and practices of computer applications in database management Strong verbal and written communication skills required. 15% - 20% travel may be required Educational Requirements: Bachelor's degree preferred Clinical experience is preferred 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. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.