Oncology Study Start-Up Manager
Location: Bangalore, India
Job Type: Full-Time
Job Requisition ID: R-247029
Application Deadline: 30 March 2026
Company Overview
AstraZeneca is a global, science-led, patient-focused biopharmaceutical organization dedicated to the discovery, development, and commercialization of innovative prescription medicines. With a strong oncology portfolio and a commitment to clinical excellence, AstraZeneca continues to advance transformative therapies for patients worldwide.
Role Overview
The Oncology Study Start-Up Manager (Onc SSU Manager) is responsible for leading and delivering site start-up and activation activities for oncology clinical trials in India. This role plays a critical part in ensuring regulatory submissions, ethics approvals, and site activation milestones are achieved efficiently and in compliance with global and local regulatory standards.
The position involves close collaboration with Clinical Research Associates (CRAs), Study Delivery Teams, Regulatory Authorities, Ethics Committees, Contracts, Feasibility teams, and Support Services to ensure timely and high-quality activation of clinical trial sites.
Key Responsibilities
Regulatory & Ethics Submissions
Prepare and submit local Regulatory Authority (RA) and Ethics Committee (EC) submission packages, including amendments.
Manage follow-up communications, queries, authorizations, and approval documentation.
Ensure compliance with ICH-GCP, AstraZeneca procedural documents, and local regulations.
Site Activation & Study Start-Up
Drive timely activation of agreed clinical trial sites.
Monitor and report site activation progress metrics to the Local Study Team (LST) and leadership.
Identify risks to activation timelines and proactively implement mitigation strategies.
Serve as primary reviewer of site-level Informed Consent Forms (ICFs), as applicable.
Documentation & Systems Management
Maintain and update Trial Master File (TMF) documentation in Veeva Clinical Vault (VCV).
Ensure completeness and quality of start-up documentation for final archiving and inspection readiness.
Manage regulatory binders and study supplies for site initiation.
Create and manage clinical-regulatory documents in ANGEL in accordance with the Global Document List (GDL).
Maintain accurate records in tracking systems such as Veeva, MS Teams, and other AstraZeneca platforms.
Quality & Compliance
Support audits and regulatory inspections in coordination with QA and Study Delivery Teams.
Ensure compliance with company policies related to ethics, safety, finance, and technology.
Contribute to process improvements and best practice sharing within the Study Activation Team.
Required Experience
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.
Minimum 3–6 years of experience in Study Management, Site Start-Up, or Clinical Operations within the pharmaceutical, biotechnology, or CRO industry.
Demonstrated experience in regulatory submissions and ethics committee interactions in India.
Strong knowledge of ICH-GCP guidelines and local regulatory requirements governing clinical trials.
Experience managing Trial Master File (TMF) documentation and electronic systems such as Veeva.
Desirable Qualifications
Advanced degree in Life Sciences or Clinical Research.
Professional certification in Clinical Research or Study Management.
Exposure to oncology clinical trials is highly preferred.
Core Competencies
Strong project management and timeline tracking skills.
Regulatory documentation expertise.
Cross-functional collaboration and stakeholder communication.
Risk identification and mitigation planning.
High attention to detail and compliance-driven mindset.
Ability to work in a fast-paced, matrixed global environment.
Why Join AstraZeneca?
Opportunity to contribute to cutting-edge oncology clinical trials.
Exposure to global clinical development programs.
Inclusive and collaborative culture focused on innovation and scientific excellence.
Career growth opportunities in global clinical operations and regulatory leadership.
SEO & GEO Keywords: Oncology Study Start-Up Manager Jobs Bangalore, Clinical Trial Site Activation India, Regulatory Submission Manager Oncology, Clinical Operations Jobs India, ICH GCP Compliance Roles, Veeva Clinical Vault Jobs, Pharmaceutical Study Management Careers, AstraZeneca Clinical Research Jobs.
This opportunity is ideal for experienced clinical operations professionals seeking oncology study start-up leadership roles in Bangalore within a globally recognized biopharmaceutical organization.
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