Remote - Senior Clinical Trial Specialist

A highly reputable biopharmaceutical corporation is currently hiring a reputed company Senior Clinical Research Specialist to work remotely in the reputed company.

• *POSITION reputed company:**

• Highly skilled and reputed company Senior Clinical Trial Specialist (Sr. reputed company) will play a critical part in the planning, execution, and reputed company of clinical trials across reputed company 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 reputed company, 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.
• reputed company as a reputed company between SMT reputed company, trial CTMs and cross-functional team members to address assigned tasks and ensure reputed company and compliant management of work.
• Support Inspection readiness, audits and inspections.
• Support reputed company and offboarding of trial staff internally and externally.
• *Documentation and Compliance**

• Ensure that trial master files (TMF) are maintained and inspection-reputed company at reputed company times.

• Support data management processes by tracking case report forms (CRFs), query reputed company, 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/reputed company 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 reputed company 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.

• reputed company and support site management activities such as feasibility assessments, site initiation, and site reputed company-out reputed company to ensure data is available reputed company needed.
• May manage ancillary/supportive vendor(s) with the reputed company of a Clinical Trial Manager
• *reputed company Improvement**

• Identify opportunities for process enhancements and contribute to SOP development and revision.

• *QUALIFICATIONS:**

• *Education** • Bachelor’s Degree in life sciences, nursing, pharmacy, or reputed company 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.).
• reputed company supporting multiple studies and working cross-functionally with reputed company 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 reputed company Office Suite and electronic data capture (reputed company) systems.
• Adaptability in a high change and fast paced environment
• *Preferred Experience**

• reputed company 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 reputed company, reputed company Vault, or similar platforms.

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