Regulatory & Start-Up Specialist
Location: Bangalore
Category: Clinical
Job ID: 262931
Role Overview
The Regulatory & Start-Up Specialist is responsible for supporting clinical trial start-up activities, with a strong focus on contract management, site agreements, protocol amendments, and regulatory coordination. The role ensures timely execution of clinical trial agreements and supports smooth study initiation and maintenance in compliance with regulatory and quality standards.
Key Responsibilities
1. Clinical Trial Agreements (CTA) & Contract Management
Draft, review, negotiate, and finalize:
Clinical Trial Agreements (CTAs)
Confidentiality Agreements (CDAs)
Amendments and related site contracts
Coordinate with sponsors, legal teams, clinical operations, and study teams for contract execution.
Ensure timely completion of contracts within study milestones and agreed timelines.
Track contract status in systems such as SAMS, UCV, and other tracking tools.
Identify risks, delays, and contract issues; escalate when necessary.
2. Site & Study Coordination
Maintain communication with study teams and sites regarding contract progress.
Ensure accurate documentation and filing of executed contracts.
Provide regular updates on contract status and outstanding issues.
3. Internal Approvals & Workflow Management
Facilitate internal approval processes for contract execution.
Ensure all required authorizations are obtained in a timely manner.
Maintain compliance with internal SOPs and workflows.
4. Protocol Amendments Support
Coordinate protocol amendment submissions and updates for assigned studies.
Review amendment requirements and communicate action items to relevant stakeholders.
Support contract and budget revisions based on protocol changes.
Track amendment timelines and ensure timely completion and implementation.
5. Cross-Functional Collaboration
Work closely with:
Clinical Operations
Regulatory Affairs
Legal teams
Finance teams
Ensure alignment and smooth execution of study start-up and amendments.
6. Documentation & System Management
Maintain accurate records in contract tracking systems.
Ensure proper upload and maintenance of amendment-related documents.
Track study metrics, reports, and status updates.
7. Risk Management & Escalation
Identify operational risks and delays impacting study timelines.
Escalate issues to management when required.
Provide proactive updates on potential risks and mitigation strategies.
8. Compliance & Quality
Ensure adherence to:
SOPs (Standard Operating Procedures)
ICH-GCP guidelines
Sponsor requirements
Quality standards
Support audit readiness through complete and accurate documentation.
9. Process Improvement
Participate in process improvement initiatives.
Contribute to enhancing efficiency in start-up and contract management processes.
10. Administrative & Operational Support
Maintain trackers, reports, and metrics.
Complete training, timesheets, and compliance requirements on time.
Support smooth operational execution of assigned studies.
Required Skills & Competencies
Strong understanding of clinical trial contracting processes
Knowledge of protocol amendments and clinical study start-up activities
Familiarity with ICH-GCP guidelines
Strong communication and negotiation skills
Stakeholder management ability
High attention to detail and accuracy
Strong organizational and multitasking skills
Ability to manage multiple studies under tight timelines
Proficiency in:
Contract tracking systems
Microsoft Office tools
Qualifications
Education
University/College degree in Life Sciences preferred
OR
Certification in allied health fields (e.g., Nursing, Medical Technology, Laboratory Technology)
Experience Requirements
3–5 years of experience in clinical research
Strong working knowledge of ICH-GCP and related regulatory guidelines
0–2 years of additional professional experience in related roles
Additional Expectations
Strong communication and organizational abilities
Ability to collaborate effectively in team environments
Consistent delivery of high-quality work
Strong computer and system proficiency
Work Environment
General office-based environment
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