other
Posted 2 weeks agoCentralized Study Analyst
at Fortrea
Bangalore, IndiaOn-site
Responsibilities
- Coordinate with sponsors, legal teams, clinical operations, and study teams to facilitate timely contract execution.
- Manage site agreement timelines and ensure contracts are completed within study milestones and agreed turnaround timelines.
- Maintain accurate contract status updates and documentation in SAMS, UCV, and other applicable systems.
- Facilitate internal approval workflows and obtain required authorizations for agreement execution.
- Track contract execution status and ensure executed documents are filed appropriately in shared repositories.
- Identify contracting risks, delays, and issues proactively and escalate to management where required.
- Coordinate protocol amendment submissions and associated documentation updates for assigned studies and sites.
- Support amendment-related contract and budget revisions in alignment with approved protocol changes. Review amendment
- Track amendment progress and ensure timely completion of submissions, approvals, and implementation activities.
- Collaborate with cross-functional teams including Clinical Operations, Regulatory, Legal, and Finance to support amendment execution.
- Ensure all amendment-related documents are uploaded and maintained accurately within applicable systems and trackers.
- Support site communications and follow-up activities to address outstanding queries and prevent delays in amendment implementation.
- Ensure adherence to SOPs, sponsor requirements, quality standards, and ICH-GCP principles.
- Maintain accurate study trackers, reports, and metrics for contract and amendment activities.
- Support audit readiness by maintaining complete and accurate documentation.
- Collaborate effectively with internal and external stakeholders to ensure efficient study execution.
- Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs), confidentiality agreements, amendments, and related site contract documentation.
Requirements
- Required Skills & Competencies Strong understanding of clinical trial contracting and protocol amendment processes.
- Knowledge of ICH-GCP guidelines and clinical research operations.