Centralized Study Specialist II
On-siteBengaluru, Karnataka, India
Job Summary
Draft, review, negotiate, and finalize Clinical Trial Agreements, confidentiality agreements, amendments, and related site contract documentation. Coordinate with sponsors, legal teams, clinical operations, and study teams to facilitate timely contract execution and manage site agreement timelines. Maintain accurate contract status updates in SAMS, UCV, and other systems while tracking amendment progress and supporting protocol amendment submissions. Identify contracting risks, delays, and issues proactively, escalate to management where required, and ensure executed documents are filed appropriately. Provide regular updates to study teams regarding contract progress, support audit readiness by maintaining complete documentation, and collaborate effectively with cross-functional teams to ensure efficient study execution. Complete assigned training, timesheets, and compliance activities within required timelines.
Required Qualifications
- University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex. Nursing certification, Medical or laboratory technology)
- 03-05 years of work experience in clinical research
- strong working knowledge of the ICH-GCP guidelines
- all other applicable guidelines and regulations
Desired Qualifications
- Strong understanding of clinical trial contracting and protocol amendment processes
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