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Job title: Clinical Trial Support Associate

• Location: Hyderabad

About the job

The Clinical Trial Support Associate (CTSA) plays a pivotal role in supporting the Clinical Operations Study Leader (COSL), Global Study Leader (GSL for EDCO) and the Clinical Operations Study Country Leader (COSCL) throughout the entire lifecycle of clinical studies. The CTSA is entrusted with managing a wide range of study, country, and site-level activities delegated by the COSL, GSL and COSCL, ensuring seamless execution and delivery of clinical trials.

As the central point of oversight, the CTSA coordinates activities across all levels within a study, maintaining a comprehensive view of study Progress. They collaborate closely with the COSL/GSL to prepare study-related plans and materials, escalate issues appropriately, identify study risks, develop contingency plans, and monitor the study plan's adherence. Additionally, the CTSA supports the COSCL in managing country or site-specific tasks, ensuring compliance and smooth operations.

The CTSA also assists in the overall management of budget tracking and invoice approval, working alongside the clinical study leader and the clinical study country leader. They liaise with site monitors as needed to ensure site-level study compliance, acting with critical thinking and a problem-solving mindset. The CTSA executes tasks with integrity, ensuring all activities are suitable for regulatory review.

Other key stakeholders include the Clinical Trial Support Manage (CTSM), vendor managers and any other study team member.

The COSL, GSL and the COSCL provide oversight of the CTSA's activities, depending on whether they pertain to study or country-level operations.

Main responsibilities include:

•  Ensure Study and  Site communication and documentation tasks

• Facilitate site and study team communication by distributing protocol amendments and Investigator Brochure updates.

• Develop and disseminate study newsletters and mass site communications (newsletters, memos).

• Maintain documentation tasks including ICF tracking logs, Patient Data Report (PDR) distribution and tracking, equipment leasing coordination, insurance request management, site training tracking, and who's who list maintenance

• Supports completion of all study documents with the various study team members

• Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant Sharepoint locations as required.

•  Ensure Financial management tasks

• Process  study, investigator and vendor payment requests, manage invoices, create and track purchase orders (POs), and report payment statuses to COSL/GSL/COSCL and site monitor.

• Track budgets at study, country, and site levels, ensuring accurate payment status reporting and effective vendor management in finance systems

•  Ensure CTMS & Systems Administration tasks

• Set up CTMS at study, country, and site levels, create and maintain site accounts, manage system access and manage tool access requests, for phase 1 studies maintain CTMS updated if applicable

• Monitor CTMS compliance, generate and distribute reports, and oversee system data quality.

• Support access management for any tool/system used for the clinical trial

• Audit and inspection administrative activities

• Conduct  IPC (In-Process Control) checks at study, country, and site levels, support inspection readiness

• Assist with audit/inspection preparation and contribute to elaborate proper responses to audit/inspections, and provide PAI (Pre-Approval Inspection) readiness admin support.

• Prepare CSR appendices, manage BIMO activities,

About you

• Bachelor's degree in life sciences, healthcare administration, or related field or equivalent experience

• Experience in clinical operations and managing clinical studies is preferred.

• Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs.

• Strong written and verbal communication skills. English language skill: ability to exchange fluently write meeting minutes/ emails/ study documents, internal & external communications.

• Good organizational skills: ability to multi-task, skill in establishing priorities and meeting deadlines

• Readily adapt to new environment, technologies and processes (e.g. new digital tools)

• Proficiency in CTMS and financial management experience or ability to quickly learn new systems and processes.

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