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.
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