- Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system.
- As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting
- Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalised
- Initiates and maintains production of study documents, ensuring template and version compliance
- Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List
- Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents
- Manages and coordinates tracking of study materials and equipment
- Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies
- Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations
- Keeps own knowledge of best practices and new relevant developments up to date
- Liaises with compliance team members to improve regulatory processes within the team
- Identifies opportunities to improve the methodology and provide practical solutions for clinical development
Typical People Management Responsibility (direct / indirect reports):
- Approximate number of people managed in total (all levels) - None
What is the global remit? (how many countries will the role operate in?):
- Own country
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
Key Relationship to reach solutions:
- Internal (to AZ or team): Study management function; Other AstraZeneca employees
- External (to AZ): External service providers and regulatory bodies
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.
Clinical Research Associate
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
- Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system.
- As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting
- Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalised
- Initiates and maintains production of study documents, ensuring template and version compliance
- Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List
- Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents
- Manages and coordinates tracking of study materials and equipment
- Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies
- Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations
- Keeps own knowledge of best practices and new relevant developments up to date
- Liaises with compliance team members to improve regulatory processes within the team
- Identifies opportunities to improve the methodology and provide practical solutions for clinical development
Typical People Management Responsibility (direct / indirect reports):
- Approximate number of people managed in total (all levels) - None
What is the global remit? (how many countries will the role operate in?):
- Own country
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
Key Relationship to reach solutions:
- Internal (to AZ or team): Study management function; Other AstraZeneca employees
- External (to AZ): External service providers and regulatory bodies
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.
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Reasons to Join
Thomas Mathisen
Christine Recchio
Stephanie Ling
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.
