Regulatory and Start-Up Specialist
Location: Bangalore, India
Employment Type: Full-Time
Department: Regulatory & Start-Up Operations
Experience Required: 3–5 Years
Industry: Clinical Research / CRO / Pharmaceutical / Life Sciences
Job Summary
The Regulatory and Start-Up Specialist is responsible for managing clinical trial site contracting and protocol amendment activities to support efficient study start-up and execution. The role involves drafting, reviewing, negotiating, tracking, and finalizing site agreements, while ensuring compliance with regulatory requirements, sponsor expectations, and internal quality standards.
The individual will collaborate closely with Clinical Operations, Regulatory Affairs, Legal, Finance, Sponsors, and Study Teams to ensure contracts, amendments, and related documentation are completed accurately and within established 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 within study milestones and turnaround expectations.
Facilitate internal approval workflows and obtain required authorizations for contract execution.
Monitor contract execution status and ensure completed agreements are appropriately filed and archived.
Maintain accurate contract records, status updates, and documentation within applicable systems including SAMS, UCV, and other contract management platforms.
Identify potential contracting risks, delays, and issues and escalate appropriately to management.
Provide regular contract status updates and reports to study teams and key stakeholders.
Protocol Amendment Management
Coordinate protocol amendment submissions and associated documentation updates for assigned studies and sites.
Support amendment-related contract and budget revisions based on approved protocol changes.
Review amendment requirements and communicate action plans, timelines, and documentation requirements to study teams and investigational sites.
Track amendment progress to ensure timely submissions, approvals, and implementation activities.
Collaborate with Clinical Operations, Regulatory Affairs, Legal, Finance, and other stakeholders to support amendment execution.
Ensure all amendment-related documentation is accurately maintained within study systems, trackers, and repositories.
Support site communication and follow-up activities to resolve outstanding issues and prevent implementation delays.
Compliance & Operational Support
Ensure adherence to SOPs, sponsor requirements, quality standards, regulatory requirements, and ICH-GCP guidelines.
Maintain accurate study trackers, reports, metrics, and documentation.
Support audit and inspection readiness through complete and compliant document management practices.
Escalate operational risks, delays, and issues that may impact study timelines or deliverables.
Participate in process improvement initiatives and departmental projects.
Collaborate effectively with internal and external stakeholders to ensure efficient study execution.
Complete assigned training, compliance activities, and timesheets within required timelines.
Required Skills & Competencies
Technical Skills
Strong understanding of Clinical Trial Agreements (CTAs) and clinical trial contracting processes.
Knowledge of protocol amendment management and study start-up activities.
Understanding of clinical research regulations and ICH-GCP guidelines.
Experience working with contract tracking systems and study management platforms.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
Core Competencies
Excellent communication and stakeholder management skills.
Strong negotiation and relationship-building abilities.
Exceptional organizational and project coordination skills.
Ability to manage multiple studies and priorities simultaneously.
Strong analytical and problem-solving capabilities.
High attention to detail and commitment to quality.
Ability to work independently and within cross-functional teams.
Proven ability to meet deadlines in a fast-paced environment.
Qualifications
Education
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Laboratory Technology, or related healthcare discipline.
OR
Certification in an allied health profession from an accredited institution.
Equivalent relevant experience may be considered in lieu of educational qualifications.
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