Remote - Senior Clinical Trial Specialist

A highly reputable biopharmaceutical corporation is currently hiring a qualified Senior Clinical Research Specialist to work remotely in the United States. • *POSITION SUMMARY:** • Highly skilled and experienced Senior Clinical Trial Specialist (Sr. CTS) will play a critical part in the planning, execution, and oversight of clinical trials across all phases, ensuring adherence to regulatory requirements and industry standards. • This position provides a unique opportunity to contribute to the development of life-changing therapies in a collaborative, fast-paced environment. • *KEY RESPONSIBILITIES:** • *Trial Operations and Support** • Assist in the tracking and filing of clinical trial protocols and study documents (informed consent forms, CRFs, lab manuals, etc.). • Manage study Management Team Meeting logistics, Meeting management, agenda creation, minutes and AI capture, tracking and closure. • Act as a liaison between SMT lead, trial CTMs and cross-functional team members to address assigned tasks and ensure quality and compliant management of work. • Support Inspection readiness, audits and inspections. • Support onboarding and offboarding of trial staff internally and externally. • *Documentation and Compliance** • Ensure that trial master files (TMF) are maintained and inspection-ready at all times. • Support data management processes by tracking case report forms (CRFs), query resolution, and database locks. • Review and ensure accuracy of clinical documentation in accordance with GCP, ICH, and applicable regulations. • Assist in submission of regulatory documents to IRBs/ECs and Health Authorities as required. • Assists in coordination of study logistics: clinical supplies, drug shipments, laboratory kits, biological samples. • Creates and maintains patient enrollment and patient visit trackers/logs. • Requests confidentiality agreements, study agreements, and clinical site budgets; tracks same documents to their final approval. • Performs data entry and/or verification into designated clinical tracking systems, including collection of information from designated clinical team members, CROs, vendors, etc. • *Vendor and Site Management** • Collaborate with CROs, labs, and other vendors to monitor timelines, performance metrics, and budget adherence as assigned. • Track and support site management activities such as feasibility assessments, site initiation, and site close-out visits to ensure data is available when needed. • May manage ancillary/supportive vendor(s) with the oversight of a Clinical Trial Manager • *Continuous Improvement** • Identify opportunities for process enhancements and contribute to SOP development and revision. • *QUALIFICATIONS:** • *Education** • Bachelor’s Degree in life sciences, nursing, pharmacy, or related field. Master’s Degree or certifications in clinical research (e.g., ACRP, SOCRA) preferred. • *Experience** • 5+ years of experience in clinical research, with at least 2 years in a sponsor or CRO setting. • Strong understanding of GCP/ICH guidelines and regulatory requirements (FDA, EMA, etc.). • Experienced supporting multiple studies and working cross-functionally with internal and external stakeholders. • *Skills** • Excellent organizational and time management skills. • Strong written and verbal communication abilities. • Detail-oriented with a high level of accuracy and problem-solving skills. • Proficiency in Microsoft Office Suite and electronic data capture (EDC) systems. • Adaptability in a high change and fast paced environment • *Preferred Experience** • Experienced with oncology, rare diseases, or other specialized therapeutic areas. • Familiarity with global trial operations and multi-country regulatory environments. • Working knowledge of clinical trial software such as Medidata, Veeva Vault, or similar platforms.