Regulatory and Start-Up Specialist
Location: Bangalore
Employment Type: Full-Time
Department: Regulatory & Start-Up
Application Deadline: July 31, 2026
Job Requisition ID: 262931
Job Summary
The Regulatory and Start-Up Specialist is responsible for managing clinical trial contracting and protocol amendment activities to ensure timely study start-up and execution. The role involves drafting and negotiating site agreements, coordinating protocol amendments, maintaining compliance with regulatory requirements, and collaborating with cross-functional stakeholders to support successful clinical trial delivery.
The position requires strong knowledge of clinical research operations, contract management, ICH-GCP guidelines, and the ability to manage multiple studies and priorities within defined timelines.
Key Responsibilities
Clinical Trial Contract Management
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 contract timelines and ensure agreements are completed according to study milestones and turnaround targets.
Maintain accurate contract documentation and status updates in SAMS, UCV, and other applicable systems.
Facilitate internal approval workflows and obtain necessary authorizations for contract execution.
Track contract progress and ensure executed agreements are appropriately filed and maintained.
Identify contracting risks, delays, and issues proactively and escalate when required.
Provide regular updates to study teams and management regarding contract status and outstanding actions.
Protocol Amendment Management
Coordinate protocol amendment submissions and associated documentation updates for assigned studies and sites.
Support amendment-related contract and budget revisions following approved protocol changes.
Review amendment requirements and communicate timelines, action items, and documentation needs to study teams and sites.
Track amendment progress and ensure timely completion of submissions, approvals, and implementation activities.
Collaborate with Clinical Operations, Regulatory Affairs, Legal, and Finance teams to ensure efficient amendment execution.
Maintain accurate amendment-related documentation and records within applicable systems and trackers.
Support site communications and follow-up activities to address outstanding issues and prevent implementation delays.
Compliance & Quality Management
Ensure adherence to SOPs, sponsor requirements, quality standards, and ICH-GCP guidelines.
Maintain study trackers, reports, metrics, and documentation for contract and amendment activities.
Escalate operational risks, delays, and challenges that may impact study deliverables.
Support audit and inspection readiness through accurate and complete documentation.
Participate in process improvement initiatives and departmental objectives.
Complete required training, compliance activities, and timesheets within established timelines.
Required Skills & Competencies
Strong understanding of Clinical Trial Agreements (CTAs) and protocol amendment processes.
Knowledge of ICH-GCP guidelines and clinical research regulations.
Excellent communication, negotiation, and stakeholder management skills.
Strong organizational, planning, and multitasking abilities.
High attention to detail and quality standards.
Ability to manage multiple studies and competing priorities simultaneously.
Proficiency with contract tracking systems and Microsoft Office applications.
Strong problem-solving and risk management capabilities.
Ability to work effectively in cross-functional and global teams.
Educational Qualifications
Minimum Required
Bachelor's Degree in Life Sciences (preferred), or
Certification in an Allied Health Profession from an accredited institution, such as:
Nursing
Medical Technology
Laboratory Technology
Other related healthcare disciplines
Equivalent relevant experience may be considered in lieu of formal educational qualifications.
Experience Requirements
Required Experience
3–5 years of experience in Clinical Research, Regulatory Start-Up, Site Contracts, Study Start-Up, or related disciplines.
Strong working knowledge of:
ICH-GCP Guidelines
Clinical Trial Regulations
Site Contracting Processes
Protocol Amendment Management
Additional Experience
0–2 years of experience in related professional roles may be considered.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Queensland |Melbourne :
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Madrid |Cebu Province :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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