Senior Centralized Study Spec
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 applicable systems while tracking amendment progress and ensuring executed documents are filed appropriately. Identify contracting risks, delays, and issues proactively and escalate to management where required. Collaborate with cross-functional teams including Clinical Operations, Regulatory, Legal, and Finance to support amendment execution and ensure adherence to SOPs, sponsor requirements, quality standards, and ICH-GCP principles. Complete assigned training, timesheets, and compliance-related 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)
- 05-08years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations
Desired Qualifications
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.