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Oncology Study Start-Up Manager

Posted date Mar. 02, 2026
Contract type Full time
Job ID R-247029
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Why choose AstraZeneca India?

Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare.

The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports.

Who do we look for?

Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Success Profile

Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Tech innovators

Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives.

Ownership takers

If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it.

Challenge seekers

Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks.

Proactive collaborators

Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best.

Responsibilities

Job ID R-247029 Date posted 03/02/2026

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Job Description / Capsule

The Oncology Study Start-Up Manager (Onc SSU Manager) has local responsibility for the delivery of site start up activities for assigned studies and are active participants in the study team(s). The Onc SSU Manager works in close collaboration with Monitors, Support Services, Research sites, Local Health Authorities and Ethics Committees and the Local Study. Delivery Team to ensure that quality and quantity of site activation deliverables are achieved in a timely and efficient manner.

The Onc SSU Manager is responsible for ensuring that all requirements for site activation are in place for the agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials and local site activation process.

An Onc SSU Manager with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Site Activation Team Leader (SATL), as appropriate locally.

Typical Accountabilities

  • Preparation & Submission of the local RA submission file following clinical trial application files dispatch & amendments dispatch
  • Preparation & Submission of the EC submission file following clinical trial application files dispatch & amendment dispatch
  • Follow up on intermediate letters, questions and answers, authorization
  • Filing of documents on AZ filing system, with support of CSA
  • Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents.
  • Assist in coordination and administration of clinical studies from start-up through site activation.
  • Actively participate in local Study Delivery Team meetings and work cross functionally with Contracts, Feasibility and Study Support Services in SM&M.
  • Activate study sites in compliance with AZ Procedural Documents.
  • Share information (metrics) on study site progress towards activation within local Study Delivery Team and SM&M leadership as required.
  • Drive delivery of regulatory documents at the sites. Proactively ensure submission and activation against effective planned timelines defined with the LST, and identify delays in start-up activities and the risks to the activation plan.
  • Primary reviewer of site level Informed Consent Forms, as locally appropriate
  • Update Veeva Clinical Vault (VCV) and other systems with data from centres as per required per SAT process, as locally appropriate.
  • Ensure regulatory binders and study supplies are provided for study site start up and/or delivered as per SAT process and agreement with Local Study Delivery Team.
  • Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
  • Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
  • Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva).
  • Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities.
  • Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
  • Contribute to the production of study start up documents, ensuring template and version compliance.
  • Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL.
  • Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. Veeva, MS Teams, Box etc) and support others in the usage of these systems.

Additional Responsibilities:

Contribute to process improvements, knowledge transfer and best practice sharing. · Proactively share applicable information that may be relevant to other functions.

Education, Qualifications, Skills and Experience

Essential:

  • Bachelor’s degree in relevant discipline
  • Experience of Study Management within a pharmaceutical or clinical background
  • Knowledge of relevant legislation and new developments in the area of Clinical Development and
  • Study Management

Desirable:

  • Advanced degree within the field
  • Professional certification
  • Understanding of multiple aspects within Study Management

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

You can find alternative messaging to use in the ‘Global Talent Attraction Story messaging’ section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

If you have site, country or departmental social media then feel free to switch any of the above links.

Date Posted

02-Mar-2026

Closing Date

30-Mar-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Reasons to Join

Thomas Mathisen

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Sales Representative Oslo, Norway

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Christine Recchio

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Sales Representative California, United States

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Stephanie Ling

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

Sales Representative Petaling Jaya, Malaysia

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

What we offer

We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you.

Lifelong learning

Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still.

Autonomy and reward

Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package.

Health and wellbeing

An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority.

Inclusion and diversity

Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.

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