Centralized Study Spec II

FTINDDDBLR Fortrea Development India Private Limited_BLR; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Fortrea Development India Private Limited in Bengaluru is seeking a contracts specialist to draft, review, negotiate, and finalize CTAs, confidentiality agreements, amendments, and related site contracts. You will coordinate with sponsors, legal teams, clinical operations, and study teams to advance timely contract execution and maintain accurate status in core systems.

Responsibilities include monitoring timelines, managing amendment submissions, and ensuring archive of executed documents.

Qualifications

• University/college degree (Life Science preferred) or allied health certification.
• 3–5 years of work experience in clinical research with ICH-GCP knowledge.

Responsibilities

• Draft, review, negotiate, and finalize CTAs, confidentiality agreements, amendments, and related site contracts.
• Coordinate with sponsors, legal teams, clinical operations, and study teams to ensure timely contract execution.
• Track contract status and milestones in SAMS, UCV, and other systems.
• Support amendment-related revisions and ensure timely submissions and approvals.
• Maintain SOP compliance, audit readiness, and documentation quality across studies.
• Escalate risks and issues to management and drive process improvement initiatives.

Skills

Contract negotiation

Stakeholder management

ICH-GCP knowledge

Documentation control

Microsoft Office

Education

Bachelor's degree in Life Sciences

Tools

SAMS

UCV

Contract tracking systems

Job description

Summary of Responsibilities: Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs), confidentiality agreements, amendments, and related site contract documentation. 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 elevate to management where required. Provide regular updates to study teams and management regarding contract progress and outstanding issues. 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 requirements and communicate action items, timelines, and documentation needs to sites and study teams. 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. Provide timely escalation of risks, delays, and operational challenges impacting study deliverables. Support audit readiness by maintaining complete and accurate documentation. Participate in process improvement initiatives and support departmental goals and objectives. Collaborate effectively with internal and external stakeholders to ensure efficient study execution. Complete assigned training, timesheets, and compliance-related activities within required timelines.

Required Skills & Competencies Strong understanding of clinical trial contracting and protocol amendment processes. Knowledge of ICH-GCP guidelines and clinical research operations. Excellent communication, negotiation, and stakeholder management skills. Strong organizational and multitasking abilities with attention to detail. Ability to manage multiple studies and priorities within tight timelines. Proficiency in contract tracking systems and Microsoft Office applications.

Qualifications (Minimum Required): 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, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.